Aortic Stenosis
Conditions
Brief summary
The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.
Interventions
DEVICELotus Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
DEVICECoreValve/Evolut R Transcatheter Aortic Valve Replacement System
Procedure: Transcatheter aortic valve replacement (TAVR)
DEVICELOTUS Edge Valve System
Procedure: Transcatheter aortic valve replacement (TAVR)
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Subject has documented calcific, severe native aortic stenosis with an initial aortic valve area (AVA) of ≤1.0 cm2 (or AVA index of ≤0.6 cm2/m2) and a mean pressure gradient \>40 mm Hg or jet velocity \>4.0 m/s, as measured by echocardiography and/or invasive hemodynamics 2. Subject has a documented aortic annulus size of ≥18 mm and ≤29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC\]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device. For the U.S. Continued Access Study cohort the acceptable aortic annulus size is ≥20 mm and ≤27 mm. 3. Subject has symptomatic aortic valve stenosis with New York Heart Association (NYHA) Functional Class ≥ II 4. There is agreement by the heart team (which must include a site investigator interventionalist and a site investigator cardiac surgeon) that subject is at high or extreme operative risk for surgical valve replacement (see note below for definitions of extreme and high risk, the required level of surgical assessment, and CRC confirmation) and that TAVR is appropriate. Additionally, subject has at least one of the following. * Society of Thoracic Surgeons (STS) score ≥8% -OR- * If STS \<8, subject has at least one of the following conditions: Hostile chest, porcelain aorta, severe pulmonary hypertension (\>60 mmHg), prior chest radiation therapy, coronary artery bypass graft(s) at risk with re-operation, severe lung disease (need for supplemental oxygen, forced expiratory volume in 1 second \[FEV1\] \<50% of predicted, diffusing capacity of the lungs for carbon monoxide \[DLCO\] \<60%, or other evidence of severe pulmonary dysfunction), neuromuscular disease that creates risk for mechanical ventilation or rehabilitation after surgical aortic valve replacement, orthopedic disease that creates risk for rehabilitation after surgical aortic valve replacement, Childs Class A or B liver disease (subjects with Childs Class C disease are not eligible for inclusion in this trial), frailty as indicated by at least one of the following: 5-meter walk \>6 seconds, Katz Assessment of Daily Living (Katz ADL) score of 3/6 or less, body mass index \<21, wheelchair bound, unable to live independently, age ≥90 years, other evidence that subject is at high or extreme risk for surgical valve replacement (CRC must confirm agreement with site heart team that subject meets high or extreme risk definition) 5. Heart team (which must include a cardiac interventionalist and an experienced cardiac surgeon) assessment that the subject is likely to benefit from valve replacement. 6. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent. 7. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits. Note: Extreme operative risk and high operative risk are defined as follows: Extreme Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥50% at 30 days; High Operative Risk: Predicted operative mortality or serious, irreversible morbidity risk ≥15% at 30 days. Risk of operative mortality and morbidity must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must include an experienced cardiac surgeon).
Exclusion criteria
1. Subject has a congenital unicuspid or bicuspid aortic valve. 2. Subject has had an acute myocardial infarction (MI) within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total creatine kinase (CK) elevation ≥ twice normal in the presence of creatine kinase-myoglobin band (CK-MB) elevation and/or troponin elevation). 3. Subject has had a cerebrovascular accident or transient ischemic attack within the past 6 months prior to study enrollment. 4. Subject has end-stage renal disease or has glomerular filtration rate (GFR) \<20 (based on Cockcroft-Gault formula). 5. Subject has a pre-existing prosthetic aortic or mitral valve. 6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation. 7. Subject has a need for emergency surgery for any reason. 8. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis. 9. Subject has echocardiographic evidence of new intra-cardiac mass, vegetation or intraventricular or paravalvular thrombus requiring intervention. 10. Subject has (hemoglobin) Hgb \<9 g/dL, platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3. 11. Subject requires chronic anticoagulation therapy after the implant procedure and cannot be treated with warfarin (other anticoagulants are not permitted in the first month) for at least 1 month concomitant with either aspirin or clopidogrel. 12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months, or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen, or will refuse transfusions. 13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to aspirin, all P2Y12 inhibitors, heparin, nickel, tantalum, titanium, or polyurethanes. 14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment. 15. Subject has hypertrophic obstructive cardiomyopathy. 16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty or pacemaker implantation, which are allowed). 17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization. 18. Subject has severe left ventricular dysfunction with ejection fraction \<20%. 19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices. 20. Subject has severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely, marked tortuosity, significant narrowing of the abdominal aorta, severe unfolding of the thoracic aorta, or symptomatic carotid or vertebral disease). 21. Subject has thick (\>5 mm) protruding or ulcerated atheroma in the aortic arch 22. Subject has arterial access that is not acceptable for the test and control device delivery systems as defined in the device Instructions For Use. 23. Subject has current problems with substance abuse (e.g., alcohol, etc.). 24. Subject is participating in another investigational drug or device study that has not reached its primary endpoint. 25. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation. 26. Subject has severe incapacitating dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Events Included in the Primary Safety Endpoint | 30 days following procedure | Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications |
| Percentage of Participants With Events Included in the Primary Effectiveness Endpoint | 1 year following procedure | Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation | 1 year following procedure | Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | at discharge or 7 days post-procedure (whichever comes first) | Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined. The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome). |
| Percentage of Participants With Clinical Procedural Success | 30 days post procedure | Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding |
| Percentage of Participants With Procedural Success | 30 days post procedure | Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area \[EOA\] \>0.9 cm2 for body surface area (BSA) \<1.6 m2 and EOA \>1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient \<20 mm Hg or a peak velocity \<3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events |
| Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity |
| Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Assessed by an independent core laboratory - mean and peak aortic gradients |
| Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Assessed by an independent core laboratory - peak aortic velocity |
| Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined. The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome). |
| Health Status as Evaluated by Quality of Life Questionnaires | Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported | SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year * SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. |
| Percentage of Participants With Mortality | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | All-cause, Cardiovascular, and Non-cardiovascular |
| Percentage of Participants With Stroke | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Disabling Stroke and Non-disabling Stroke |
| Percentage of Participants With Myocardial Infarction (MI) | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Periprocedural (≤72 hours post index procedure) and spontaneous (\>72 hours post index procedure) |
| Percentage of Participants With Bleeding | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Life-threatening (or disabling) and major (defined below) Life-threatening or Disabling Bleeding * Fatal bleeding (Bleeding Academic Research Consortium \[BARC\] type 5124,125) * Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) * Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) * Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b) Major Bleeding (BARC type 3a) * Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding |
| Percentage of Participants With Successful Deployment of the Study Valve | at discharge or 7 days post-procedure (whichever comes first) | Successful deployment of the study valve |
| Percentage of Participants With Major Vascular Complication | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Major vascular complication - including access site related and non access site related |
| Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Repeat procedure for valve-related dysfunction (surgical or interventional therapy) |
| Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association \[NYHA\] class III or IV) |
| Percentage of Participants With New Permanent Pacemaker Implantation | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | New permanent pacemaker implantation resulting from new or worsened conduction disturbances |
| Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | New onset of atrial fibrillation or atrial flutter |
| Percentage of Participants With Coronary Obstruction | ≤72 hours post index procedure | Coronary obstruction |
| Percentage of Participants With Ventricular Septal Perforation | ≤72 hours post index procedure | Ventricular septal perforation |
| Percentage of Participants With Mitral Apparatus Damage | ≤72 hours post index procedure | Mitral apparatus damage |
| Percentage of Participants With Cardiac Tamponade | ≤72 hours post index procedure | Cardiac tamponade |
| Percentage of Participants With Prosthetic Aortic Valve Malpositioning | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment |
| Percentage of Participants With Prosthetic Aortic Valve Thrombosis | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Prosthetic aortic valve thrombosis |
| Percentage of Participants With Prosthetic Aortic Valve Endocarditis | assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported. | Prosthetic aortic valve endocarditis |
| Percentage of Participants With Acute Kidney Injury | ≤7 days post index procedure | Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2 Change in serum creatinine (up to 7 days) compared to baseline: * Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L) * Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline) * Stage 3: Increase in serum creatinine to ≥300% (\>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) -OR- Based on urine output (up to 7 days): * Stage 1: \<0.5 ml/kg per hour for \>6 but \<12 hours * Stage 2: \<0.5 ml/kg per hour for \>12 but \<24 hours * Stage 3: \<0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria. |
| Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted | at discharge or 7 days post-procedure (whichever comes first) | Successful retrieval of the study valve if retrieval is attempted |
| Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted | at discharge or 7 days post-procedure (whichever comes first) | Successful repositioning of the study valve if repositioning is attempted |
Countries
Australia, Canada, France, Germany, Netherlands, United States
Participant flow
Recruitment details
912 subjects randomized from 22Sep2014 to 24Dec2015. 102 subjects enrolled in the Roll-in cohort. 295 subjects enrolled in the US CAS from 25Feb2016 to 23Feb2017. Enrollment in the LOTUS Edge Valve System - Single-arm Edge Nested Reg is ongoing. Enrollment in the LOTUS Edge Valve System - Single-arm 29mm Reg and Roll-in Cohorts has not begun.
Pre-assignment details
The non-randomized Roll-In phase with only the test device was for centers with no previous experience implanting the Lotus Valve System. Each performed at least two Roll-In cases before starting RCT. Only cohorts that have completed enrollment, reached primary endpoint and were submitted for regulatory approval are included in the Results Section
Participants by arm
| Arm | Count |
|---|---|
| Lotus Valve System - Randomized Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR) | 607 |
| CoreValve TAVR System - Randomized Transcatheter aortic valve replacement (TAVR) with CoreValve Transcatheter Aortic Valve Replacement System
CoreValve Transcatheter Aortic Valve Replacement System: Procedure: Transcatheter aortic valve replacement (TAVR) | 305 |
| Lotus Valve System - Single-arm Roll-in Cohort Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR) | 102 |
| Lotus Valve System - Single-arm Continued Access Cohort Transcatheter aortic valve replacement (TAVR) with Lotus Valve System
Lotus Valve System: Procedure: Transcatheter aortic valve replacement (TAVR) | 295 |
| Total | 1,309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Completed Study | 1 | 0 | 0 | 0 |
| Overall Study | Death | 70 | 39 | 13 | 27 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 |
| Overall Study | Other | 1 | 0 | 0 | 1 |
| Overall Study | Physician Decision | 2 | 3 | 0 | 0 |
| Overall Study | Visit Missed | 21 | 12 | 0 | 5 |
| Overall Study | Withdrawal by Subject | 13 | 14 | 1 | 4 |
Baseline characteristics
| Characteristic | Lotus Valve System - Randomized | Total | Lotus Valve System - Single-arm Continued Access Cohort | Lotus Valve System - Single-arm Roll-in Cohort | CoreValve TAVR System - Randomized |
|---|---|---|---|---|---|
| Age, Continuous CoreValve TAVR System - Randomize | 0 Years STANDARD_DEVIATION 0 | 82.9 Years STANDARD_DEVIATION 7.6 | 0 Years STANDARD_DEVIATION 0 | 0 Years STANDARD_DEVIATION 0 | 82.9 Years STANDARD_DEVIATION 7.6 |
| Age, Continuous Lotus Valve System - Randomized | 82.8 Years STANDARD_DEVIATION 7.1 | 82.8 Years STANDARD_DEVIATION 7.1 | 0 Years STANDARD_DEVIATION 0 | 0 Years STANDARD_DEVIATION 0 | 0 Years STANDARD_DEVIATION 0 |
| Age, Continuous Lotus Valve System - Single-arm Continued Access | 0 Years STANDARD_DEVIATION 0 | 81.7 Years STANDARD_DEVIATION 6.6 | 81.7 Years STANDARD_DEVIATION 6.6 | 0 Years STANDARD_DEVIATION 0 | 0 Years STANDARD_DEVIATION 0 |
| Age, Continuous Lotus Valve System - Single-arm Roll-in Cohort | 0 Years STANDARD_DEVIATION 0 | 83.6 Years STANDARD_DEVIATION 6.9 | 0 Years STANDARD_DEVIATION 0 | 83.6 Years STANDARD_DEVIATION 6.9 | 0 Years STANDARD_DEVIATION 0 |
| European System for Cardiac Operative Risk Evaluation (EuroSCORE) CoreValve TAVR System - Randomized | 0 Percent STANDARD_DEVIATION 0 | 6.4 Percent STANDARD_DEVIATION 5.5 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 | 6.4 Percent STANDARD_DEVIATION 5.5 |
| European System for Cardiac Operative Risk Evaluation (EuroSCORE) Lotus Valve System - Randomized | 6.4 Percent STANDARD_DEVIATION 5.5 | 6.4 Percent STANDARD_DEVIATION 5.5 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 |
| European System for Cardiac Operative Risk Evaluation (EuroSCORE) Lotus Valve System - Single-arm Continued Access | 0 Percent STANDARD_DEVIATION 0 | 5.3 Percent STANDARD_DEVIATION 5.9 | 5.3 Percent STANDARD_DEVIATION 5.9 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 |
| European System for Cardiac Operative Risk Evaluation (EuroSCORE) Lotus Valve System - Single-arm Roll-in Cohort | 0 Percent STANDARD_DEVIATION 0 | 6.4 Percent STANDARD_DEVIATION 6.5 | 0 Percent STANDARD_DEVIATION 0 | 6.4 Percent STANDARD_DEVIATION 6.5 | 0 Percent STANDARD_DEVIATION 0 |
| New York Heart Association (NYHA) Classification NYHA I | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| New York Heart Association (NYHA) Classification NYHA II | 174 Participants | 402 Participants | 108 Participants | 22 Participants | 98 Participants |
| New York Heart Association (NYHA) Classification NYHA III | 386 Participants | 813 Participants | 171 Participants | 70 Participants | 186 Participants |
| New York Heart Association (NYHA) Classification NYHA IV | 47 Participants | 94 Participants | 16 Participants | 10 Participants | 21 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 9 Participants | 4 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black, of African Heritage | 17 Participants | 45 Participants | 13 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized Caucasian | 537 Participants | 1172 Participants | 271 Participants | 93 Participants | 271 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 18 Participants | 30 Participants | 6 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 8 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 28 Participants | 43 Participants | 0 Participants | 1 Participants | 14 Participants |
| Region of Enrollment Australia | 15 participants | 23 participants | 0 participants | 0 participants | 8 participants |
| Region of Enrollment Canada | 1 participants | 4 participants | 0 participants | 2 participants | 1 participants |
| Region of Enrollment France | 23 participants | 36 participants | 0 participants | 0 participants | 13 participants |
| Region of Enrollment Germany | 33 participants | 53 participants | 0 participants | 0 participants | 20 participants |
| Region of Enrollment Netherlands | 4 participants | 6 participants | 0 participants | 0 participants | 2 participants |
| Region of Enrollment United States | 531 participants | 1187 participants | 295 participants | 100 participants | 261 participants |
| Sex: Female, Male Female | 304 Participants | 652 Participants | 137 Participants | 52 Participants | 159 Participants |
| Sex: Female, Male Male | 303 Participants | 657 Participants | 158 Participants | 50 Participants | 146 Participants |
| Society of Thoracic Surgeons (STS) Risk Score CoreValve TAVR System - Randomized | 0 Percent STANDARD_DEVIATION 0 | 6.9 Percent STANDARD_DEVIATION 4.1 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 | 6.9 Percent STANDARD_DEVIATION 4.1 |
| Society of Thoracic Surgeons (STS) Risk Score Lotus Valve System - Randomized | 6.7 Percent STANDARD_DEVIATION 4 | 6.7 Percent STANDARD_DEVIATION 4 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 |
| Society of Thoracic Surgeons (STS) Risk Score Lotus Valve System - Single-arm Continued Access | 0 Percent STANDARD_DEVIATION 0 | 5.4 Percent STANDARD_DEVIATION 2.9 | 5.4 Percent STANDARD_DEVIATION 2.9 | 0 Percent STANDARD_DEVIATION 0 | 0 Percent STANDARD_DEVIATION 0 |
| Society of Thoracic Surgeons (STS) Risk Score Lotus Valve System - Single-arm Roll-in Cohort | 0 Percent STANDARD_DEVIATION 0 | 7.0 Percent STANDARD_DEVIATION 4.9 | 0 Percent STANDARD_DEVIATION 0 | 7.0 Percent STANDARD_DEVIATION 4.9 | 0 Percent STANDARD_DEVIATION 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 70 / 587 | 40 / 297 | 13 / 101 | 27 / 293 |
| other Total, other adverse events | 458 / 607 | 210 / 305 | 83 / 102 | 228 / 295 |
| serious Total, serious adverse events | 431 / 607 | 207 / 305 | 72 / 102 | 229 / 295 |
Outcome results
Primary
Percentage of Participants With Events Included in the Primary Effectiveness Endpoint
Composite of all-cause mortality, disabling stroke, or moderate or greater paravalvular aortic regurgitation (based on core lab assessment).
Time frame: 1 year following procedure
Population: Non-inferiority analysis - Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device.~Superiority analysis - Intent to Treat Population The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Events Included in the Primary Effectiveness Endpoint | Implanted | 15.4 Percent of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Events Included in the Primary Effectiveness Endpoint | Intent to Treat | 15.8 Percent of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Events Included in the Primary Effectiveness Endpoint | Implanted | 25.5 Percent of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Events Included in the Primary Effectiveness Endpoint | Intent to Treat | 26.0 Percent of Participants |
p-value: <0.0001Farrington-Manning
Comparison: Superiority analysis was only to be run if the non-inferiority analysis was met.~Superiority analysis was run on Intent to Treat Population.p-value: 0.000695% CI: [-16.3, -4]Chi-squared
Primary
Percentage of Participants With Events Included in the Primary Safety Endpoint
Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications
Time frame: 30 days following procedure
Population: Implanted population - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are implanted with the assigned, randomized study device. The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Events Included in the Primary Safety Endpoint | 20.3 Percent of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Events Included in the Primary Safety Endpoint | 17.2 Percent of participants |
p-value: 0.0027Farrington-Manning
Secondary
Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation
Moderate or greater paravalvular aortic regurgitation based on Independent echocardiographic core lab assessment performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation by Pibarot et al (J Am Coll Cardiol Img 2015: 8: 340-60). The grading scheme ranges from Trace (the least clinically significant) to severe (the most clinically significant).
Time frame: 1 year following procedure
Population: ITT - all subjects who sign an Informed Consent Form, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted.~The Primary and Secondary Endpoints (Outcome Measures 1-3) are only applicable to the two Randomized arms of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation | 0.9 Percent of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Moderate or Greater Paravalvular Aortic Regurgitation | 6.9 Percent of Participants |
p-value: <0.000195% CI: [-9.6, -2.6]Chi-squared
Other Pre-specified
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1
Assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, and peak aortic velocity
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | Discharge or 7 Days - Aortic Valve Area | 1.65 cm^2 | Standard Deviation 0.47 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 30 Days - Aortic Valve Area | 1.59 cm^2 | Standard Deviation 0.45 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 6 Months - Aortic Valve Area | 1.46 cm^2 | Standard Deviation 0.46 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 1 Year - Aortic Valve Area | 1.49 cm^2 | Standard Deviation 0.45 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 30 Days - Aortic Valve Area | 1.98 cm^2 | Standard Deviation 0.51 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 6 Months - Aortic Valve Area | 1.74 cm^2 | Standard Deviation 0.55 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 1 Year - Aortic Valve Area | 1.69 cm^2 | Standard Deviation 0.52 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | Discharge or 7 Days - Aortic Valve Area | 1.96 cm^2 | Standard Deviation 0.52 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 6 Months - Aortic Valve Area | 1.55 cm^2 | Standard Deviation 0.45 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 30 Days - Aortic Valve Area | 1.62 cm^2 | Standard Deviation 0.46 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 1 Year - Aortic Valve Area | 1.53 cm^2 | Standard Deviation 0.49 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | Discharge or 7 Days - Aortic Valve Area | 1.70 cm^2 | Standard Deviation 0.49 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 1 Year - Aortic Valve Area | 1.51 cm^2 | Standard Deviation 0.46 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 30 Days - Aortic Valve Area | 1.55 cm^2 | Standard Deviation 0.41 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | Discharge or 7 Days - Aortic Valve Area | 1.61 cm^2 | Standard Deviation 0.42 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 1 | 6 Months - Aortic Valve Area | 1.56 cm^2 | Standard Deviation 0.47 |
Other Pre-specified
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2
Assessed by an independent core laboratory - mean and peak aortic gradients
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Mean Aortic Valve Gradient | 12.20 mmHg | Standard Deviation 5.21 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Peak Aortic Gradient | 22.28 mmHg | Standard Deviation 10.23 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Mean Aortic Valve Gradient | 12.00 mmHg | Standard Deviation 6.08 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Peak Aortic Gradient | 21.46 mmHg | Standard Deviation 10.27 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Mean Aortic Valve Gradient | 11.93 mmHg | Standard Deviation 5.21 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Peak Aortic Gradient | 22.24 mmHg | Standard Deviation 9.82 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Mean Aortic Valve Gradient | 12.29 mmHg | Standard Deviation 5.83 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Peak Aortic Gradient | 22.74 mmHg | Standard Deviation 10.53 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Peak Aortic Gradient | 14.84 mmHg | Standard Deviation 7.46 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Mean Aortic Valve Gradient | 7.89 mmHg | Standard Deviation 4.24 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Peak Aortic Gradient | 15.21 mmHg | Standard Deviation 7.2 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Peak Aortic Gradient | 15.22 mmHg | Standard Deviation 6.44 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Mean Aortic Valve Gradient | 7.89 mmHg | Standard Deviation 3.48 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Peak Aortic Gradient | 13.59 mmHg | Standard Deviation 6.21 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Mean Aortic Valve Gradient | 7.25 mmHg | Standard Deviation 3.44 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Mean Aortic Valve Gradient | 8.19 mmHg | Standard Deviation 3.98 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Mean Aortic Valve Gradient | 12.30 mmHg | Standard Deviation 7.39 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Mean Aortic Valve Gradient | 12.76 mmHg | Standard Deviation 8.24 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Peak Aortic Gradient | 23.02 mmHg | Standard Deviation 13.43 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Mean Aortic Valve Gradient | 12.33 mmHg | Standard Deviation 5.89 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Peak Aortic Gradient | 22.85 mmHg | Standard Deviation 10.6 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Peak Aortic Gradient | 22.03 mmHg | Standard Deviation 12.05 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Mean Aortic Valve Gradient | 12.13 mmHg | Standard Deviation 5.13 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Peak Aortic Gradient | 21.58 mmHg | Standard Deviation 8.55 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Mean Aortic Valve Gradient | 12.24 mmHg | Standard Deviation 6.73 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 30 Days - Peak Aortic Gradient | 22.56 mmHg | Standard Deviation 11.44 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Peak Aortic Gradient | 22.89 mmHg | Standard Deviation 10.91 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | Discharge or 7 Days - Mean Aortic Valve Gradient | 12.50 mmHg | Standard Deviation 6.01 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Mean Aortic Valve Gradient | 12.20 mmHg | Standard Deviation 5.42 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Peak Aortic Gradient | 23.75 mmHg | Standard Deviation 9.83 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 1 Year - Mean Aortic Valve Gradient | 12.68 mmHg | Standard Deviation 5.62 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 2 | 6 Months - Peak Aortic Gradient | 22.68 mmHg | Standard Deviation 9.81 |
Other Pre-specified
Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3
Assessed by an independent core laboratory - peak aortic velocity
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 6 Months - Peak Aortic Velocity | 2.30 m/s | Standard Deviation 0.46 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 30 Days - Peak Aortic Velocity | 2.26 m/s | Standard Deviation 0.46 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | Discharge or 7 Days - Peak Aortic Velocity | 2.30 m/s | Standard Deviation 0.48 |
| Lotus Valve System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 1 Year - Peak Aortic Velocity | 2.33 m/s | Standard Deviation 0.51 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 1 Year - Peak Aortic Velocity | 1.91 m/s | Standard Deviation 0.41 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | Discharge or 7 Days - Peak Aortic Velocity | 1.89 m/s | Standard Deviation 0.45 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 6 Months - Peak Aortic Velocity | 1.87 m/s | Standard Deviation 0.44 |
| CoreValve TAVR System - Randomized | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 30 Days - Peak Aortic Velocity | 1.80 m/s | Standard Deviation 0.4 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | Discharge or 7 Days - Peak Aortic Velocity | 2.28 m/s | Standard Deviation 0.44 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 1 Year - Peak Aortic Velocity | 2.28 m/s | Standard Deviation 0.55 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 30 Days - Peak Aortic Velocity | 2.33 m/s | Standard Deviation 0.58 |
| Lotus Valve System - Single-arm Roll-in Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 6 Months - Peak Aortic Velocity | 2.32 m/s | Standard Deviation 0.49 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 30 Days - Peak Aortic Velocity | 2.31 m/s | Standard Deviation 0.53 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 1 Year - Peak Aortic Velocity | 2.39 m/s | Standard Deviation 0.47 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | 6 Months - Peak Aortic Velocity | 2.33 m/s | Standard Deviation 0.49 |
| Lotus Valve System - Single-arm Continued Access Cohort | Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 3 | Discharge or 7 Days - Peak Aortic Velocity | 2.33 m/s | Standard Deviation 0.53 |
Other Pre-specified
Health Status as Evaluated by Quality of Life Questionnaires
SF-12 and Kansas City Cardiomyopathy - Baseline scores and changes from Baseline at 30 days, 6 months and 1 year * SF-12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Assessed at Baseline, 1 and 6 months; and 1, 3, and 5 years, at Baseline, 1 and 6 months and 1 Year reported
Population: Intent to Treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Clinical Summary Score | 55.2 Score on a scale | Standard Deviation 23.3 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Physical Summary | 5.8 Score on a scale | Standard Deviation 10.8 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Mental Health Sum | 3.5 Score on a scale | Standard Deviation 11.5 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Overall Summary Score | 51.9 Score on a scale | Standard Deviation 23.5 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Mental Health Sum | 3.3 Score on a scale | Standard Deviation 11.2 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Clinical Summary Score | 16.3 Score on a scale | Standard Deviation 23.8 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Overal Summary Score | 22.9 Score on a scale | Standard Deviation 23.8 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Clinical Summary Score | 17.8 Score on a scale | Standard Deviation 22.7 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Physical Summary | 4.7 Score on a scale | Standard Deviation 10.9 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Physical Summary Score | 31.9 Score on a scale | Standard Deviation 9 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Physical Summary | 5.1 Score on a scale | Standard Deviation 10.5 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Mental Health Summary Score | 49.6 Score on a scale | Standard Deviation 11.6 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Mental Health S | 3.4 Score on a scale | Standard Deviation 12.5 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Overall Summary | 20.9 Score on a scale | Standard Deviation 24.2 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Overall Summary Score | 21.6 Score on a scale | Standard Deviation 24.4 |
| Lotus Valve System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Clinical Summary | 17.4 Score on a scale | Standard Deviation 23.9 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Mental Health Summary Score | 49.0 Score on a scale | Standard Deviation 11.6 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Overall Summary | 20.2 Score on a scale | Standard Deviation 24 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Physical Summary | 5.6 Score on a scale | Standard Deviation 10.1 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Physical Summary | 6.0 Score on a scale | Standard Deviation 10 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Physical Summary | 5.2 Score on a scale | Standard Deviation 10.1 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Clinical Summary | 16.6 Score on a scale | Standard Deviation 22.9 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Mental Health Sum | 3.3 Score on a scale | Standard Deviation 12.6 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Overall Summary Score | 21.4 Score on a scale | Standard Deviation 23.2 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Overall Summary Score | 50.7 Score on a scale | Standard Deviation 22.1 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Mental Health S | 2.3 Score on a scale | Standard Deviation 12.6 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Overal Summary Score | 22.7 Score on a scale | Standard Deviation 22.6 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Clinical Summary Score | 15.0 Score on a scale | Standard Deviation 21.5 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Mental Health Sum | 3.7 Score on a scale | Standard Deviation 12.9 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Clinical Summary Score | 54.9 Score on a scale | Standard Deviation 21.9 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Clinical Summary Score | 17.0 Score on a scale | Standard Deviation 22.2 |
| CoreValve TAVR System - Randomized | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Physical Summary Score | 31.2 Score on a scale | Standard Deviation 8.9 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Physical Summary Score | 33.8 Score on a scale | Standard Deviation 10.5 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Physical Summary | 3.0 Score on a scale | Standard Deviation 10.8 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Mental Health Sum | 3.2 Score on a scale | Standard Deviation 12.5 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Overall Summary Score | 23.2 Score on a scale | Standard Deviation 26.7 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Clinical Summary Score | 57.3 Score on a scale | Standard Deviation 23.7 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Clinical Summary Score | 15.6 Score on a scale | Standard Deviation 26.8 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Physical Summary | 3.3 Score on a scale | Standard Deviation 10.5 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Mental Health S | 1.8 Score on a scale | Standard Deviation 11.3 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Overall Summary | 17.4 Score on a scale | Standard Deviation 25.6 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Mental Health Summary Score | 49.8 Score on a scale | Standard Deviation 11 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Clinical Summary | 15.2 Score on a scale | Standard Deviation 24.5 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Physical Summary | 3.6 Score on a scale | Standard Deviation 9.8 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Mental Health Sum | 2.8 Score on a scale | Standard Deviation 10.5 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Overal Summary Score | 23.5 Score on a scale | Standard Deviation 25.5 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Overall Summary Score | 52.7 Score on a scale | Standard Deviation 24.6 |
| Lotus Valve System - Single-arm Roll-in Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Clinical Summary Score | 17.5 Score on a scale | Standard Deviation 24 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Clinical Summary Score | 14.0 Score on a scale | Standard Deviation 21.7 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Physical Summary Score | 32.4 Score on a scale | Standard Deviation 10 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline SF-12 Mental Health Summary Score | 50.0 Score on a scale | Standard Deviation 11.4 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Overall Summary Score | 53.5 Score on a scale | Standard Deviation 22.8 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | Baseline KC Clinical Summary Score | 57.6 Score on a scale | Standard Deviation 22.6 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Physical Summary | 4.3 Score on a scale | Standard Deviation 9.8 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline SF-12 Mental Health S | 3.2 Score on a scale | Standard Deviation 10.6 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Overall Summary | 18.3 Score on a scale | Standard Deviation 23.1 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 30 Day change from Baseline KC Clinical Summary | 14.8 Score on a scale | Standard Deviation 22.2 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Physical Summary | 4.7 Score on a scale | Standard Deviation 10.7 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline SF-12 Mental Health Sum | 3.3 Score on a scale | Standard Deviation 11.6 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Overal Summary Score | 21.2 Score on a scale | Standard Deviation 23.1 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Physical Summary | 3.7 Score on a scale | Standard Deviation 10.6 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 6M change from Baseline KC Clinical Summary Score | 15.9 Score on a scale | Standard Deviation 22.2 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline SF-12 Mental Health Sum | 3.0 Score on a scale | Standard Deviation 11.1 |
| Lotus Valve System - Single-arm Continued Access Cohort | Health Status as Evaluated by Quality of Life Questionnaires | 1Y change from Baseline KC Overall Summary Score | 20.0 Score on a scale | Standard Deviation 22.2 |
Other Pre-specified
Percentage of Participants With Acute Kidney Injury
Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2 Change in serum creatinine (up to 7 days) compared to baseline: * Stage 1: Increase in serum creatinine to 150-199% (1.5-1.99 × increase compared with baseline) OR increase of ≥0.3 mg/dl (≥26.4 mmol/L) * Stage 2: Increase in serum creatinine to 200-299% (2.0-2.99 × increase compared with baseline) * Stage 3: Increase in serum creatinine to ≥300% (\>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) -OR- Based on urine output (up to 7 days): * Stage 1: \<0.5 ml/kg per hour for \>6 but \<12 hours * Stage 2: \<0.5 ml/kg per hour for \>12 but \<24 hours * Stage 3: \<0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours Note 1: Subjects receiving renal replacement therapy are considered to meet Stage 3 criteria irrespective of other criteria.
Time frame: ≤7 days post index procedure
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Acute Kidney Injury | Acute Kidney Injury - Stage 2 or Stage 3 | 2.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Acute Kidney Injury | Stage 3 (including renal replacement therapy) | 1.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Acute Kidney Injury | Stage 2 | 1.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Acute Kidney Injury | Acute Kidney Injury - Stage 2 or Stage 3 | 3.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Acute Kidney Injury | Stage 3 (including renal replacement therapy) | 2.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Acute Kidney Injury | Stage 2 | 1.3 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Acute Kidney Injury | Stage 2 | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Acute Kidney Injury | Acute Kidney Injury - Stage 2 or Stage 3 | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Acute Kidney Injury | Stage 3 (including renal replacement therapy) | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Acute Kidney Injury | Acute Kidney Injury - Stage 2 or Stage 3 | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Acute Kidney Injury | Stage 3 (including renal replacement therapy) | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Acute Kidney Injury | Stage 2 | 0.0 Percentage of participants |
Other Pre-specified
Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4
Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined. The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild | 11.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular None | 77.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular - Trace or Greater | 22.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular None | 72.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular AR but Severity not evaluable | 2.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular AR but Severity not evaluable | 5.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate or Greater | 0.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Trace/Trivial | 10.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate-Severe | 0.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild | 10.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild | 11.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate | 0.4 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate or Greater | 0.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Trace/Trivial | 5.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular None | 79.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate | 0.4 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular - Trace or Greater | 20.1 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular AR but Severity not evaluable | 5.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Trace/Trivial | 10.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate or Greater | 0.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular None | 73.1 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate-Severe | 0.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular - Trace or Greater | 26.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate or Greater | 0.4 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate | 0.4 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge ParavalvularAR but Severity not evaluabl | 4.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate | 0.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild | 11.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Trace/Trivial | 4.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular - Trace or Greater | 27.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate | 4.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular - Trace or Greater | 72.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular None | 27.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Trace/Trivial | 18.1 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild | 46.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate | 3.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Severe | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate or Greater | 3.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge ParavalvularAR but Severity not evaluabl | 4.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular - Trace or Greater | 75.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular None | 24.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Trace/Trivial | 14.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild | 48.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate | 7.2 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Severe | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate or Greater | 7.2 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular AR but Severity not evaluable | 4.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular - Trace or Greater | 62.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular None | 37.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Trace/Trivial | 6.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild | 42.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Severe | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate or Greater | 4.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular AR but Severity not evaluable | 8.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular - Trace or Greater | 63.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular None | 37.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Trace/Trivial | 10.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild | 38.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate | 5.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate-Severe | 0.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Severe | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate or Greater | 6.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular AR but Severity not evaluable | 6.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate or Greater | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular - Trace or Greater | 24.4 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Trace/Trivial | 7.1 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular None | 71.6 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular None | 75.6 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular None | 76.2 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Trace/Trivial | 4.7 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge ParavalvularAR but Severity not evaluabl | 3.2 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate or Greater | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild | 14.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular - Trace or Greater | 28.4 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild | 12.6 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild | 14.3 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild | 15.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular - Trace or Greater | 30.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular - Trace or Greater | 23.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Trace/Trivial | 10.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular AR but Severity not evaluable | 5.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate or Greater | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate or Greater | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular None | 70.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular AR but Severity not evaluable | 2.4 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular AR but Severity not evaluable | 4.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Trace/Trivial | 12.6 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Trace/Trivial | 3.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular - Trace or Greater | 26.9 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate | 1.2 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular None | 73.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge ParavalvularAR but Severity not evaluabl | 6.9 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Trace/Trivial | 4.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild | 19.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate or Greater | 0.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular None | 71.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular Moderate or Greater | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Moderate | 0.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 6 Month Paravalvular AR but Severity not evaluable | 2.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular - Trace or Greater | 20.6 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular None | 79.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular AR but Severity not evaluable | 3.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Mild | 18.2 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild | 12.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild | 18.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Moderate or Greater | 1.2 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate | 1.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Trace/Trivial | 2.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate-Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 1 Year Paravalvular Mild-Moderate | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Severe | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular None | 72.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular Trace/Trivial | 2.9 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular Moderate or Greater | 1.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | Discharge Paravalvular - Trace or Greater | 28.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular AR but Severity not evaluable | 4.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Additional Indications of Prosthetic Aortic Valve Performance as Measured by Transthoracic Echocardiography 4 | 30 Day Paravalvular - Trace or Greater | 27.3 Percentage of participants |
Other Pre-specified
Percentage of Participants With Bleeding
Life-threatening (or disabling) and major (defined below) Life-threatening or Disabling Bleeding * Fatal bleeding (Bleeding Academic Research Consortium \[BARC\] type 5124,125) * Bleeding in a critical organ, such as intracranial, intraspinal, intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) * Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) * Overt source of bleeding with drop in hemoglobin of ≥5 g/dL or whole blood or packed red blood cells (RBC) transfusion ≥4 units (BARC type 3b) Major Bleeding (BARC type 3a) * Overt bleeding either associated with a drop in the hemoglobin level of at least 3.0g/dL or requiring transfusion of 2 or 3 units of whole blood/RBC, or causing hospitalization or permanent injury, or requiring surgery AND does not meet criteria of life-threatening or disabling bleeding
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 1 Year Bleeding | 18.1 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | Discharge Life-threatening or Disabling Bleeding | 7.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 6 Month Life-threatening or Disabling Bleeding | 9.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | Discharge Major Bleeding | 4.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 6 Month Major Bleeding | 7.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | Discharge Bleeding | 11.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 1 Year Major Bleeding | 8.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 30 Day Bleeding | 12.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 1 Year Life-threatening or Disabling Bleeding | 9.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 30 Day Life-threatening or Disabling Bleeding | 8.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 30 Day Major Bleeding | 4.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Bleeding | 6 Month Bleeding | 16.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 1 Year Bleeding | 17.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 6 Month Bleeding | 17.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 30 Day Bleeding | 10.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 6 Month Major Bleeding | 8.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | Discharge Bleeding | 10.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 6 Month Life-threatening or Disabling Bleeding | 9.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 1 Year Major Bleeding | 8.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 30 Day Major Bleeding | 5.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | Discharge Life-threatening or Disabling Bleeding | 5.9 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 30 Day Life-threatening or Disabling Bleeding | 5.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | Discharge Major Bleeding | 4.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Bleeding | 1 Year Life-threatening or Disabling Bleeding | 9.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 6 Month Life-threatening or Disabling Bleeding | 14.7 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | Discharge Major Bleeding | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | Discharge Bleeding | 8.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | Discharge Life-threatening or Disabling Bleeding | 7.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 30 Day Bleeding | 11.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 30 Day Life-threatening or Disabling Bleeding | 9.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 30 Day Major Bleeding | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 6 Month Bleeding | 17.6 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 6 Month Major Bleeding | 2.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 1 Year Bleeding | 20.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 1 Year Life-threatening or Disabling Bleeding | 16.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Bleeding | 1 Year Major Bleeding | 5.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 30 Day Major Bleeding | 5.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 30 Day Life-threatening or Disabling Bleeding | 6.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | Discharge Bleeding | 9.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 1 Year Bleeding | 19.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 30 Day Bleeding | 11.9 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | Discharge Major Bleeding | 4.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 1 Year Major Bleeding | 8.9 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 1 Year Life-threatening or Disabling Bleeding | 11.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 6 Month Life-threatening or Disabling Bleeding | 8.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 6 Month Bleeding | 14.9 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | Discharge Life-threatening or Disabling Bleeding | 5.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Bleeding | 6 Month Major Bleeding | 6.8 Percentage of participants |
Other Pre-specified
Percentage of Participants With Cardiac Tamponade
Cardiac tamponade
Time frame: ≤72 hours post index procedure
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Cardiac Tamponade | 2.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Cardiac Tamponade | 1.3 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Cardiac Tamponade | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Cardiac Tamponade | 1.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With Clinical Procedural Success
Defined as implantation of the study device in the absence of death, disabling stroke, major vascular complications, and life-threatening or major bleeding
Time frame: 30 days post procedure
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Clinical Procedural Success | 81.4 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Clinical Procedural Success | 84.6 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Clinical Procedural Success | 81.4 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Clinical Procedural Success | 81.0 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Coronary Obstruction
Coronary obstruction
Time frame: ≤72 hours post index procedure
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Coronary Obstruction | 0.2 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Coronary Obstruction | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Coronary Obstruction | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Coronary Obstruction | 0.7 Percentage of participants |
Other Pre-specified
Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined
Grade of aortic valve regurgitation: paravalvular, central, and combined. An Independent echocardiographic core lab assessment was performed using the Unifying 5-Class Grading Scheme for Aortic Regurgitation for the locations paravalvular, central and combined. The grading scheme has a range from Trace to Severe. A grade of Trace is the least clinically significant (better outcome) and a grade of Severe is the most clinically significant (worse outcome).
Time frame: at discharge or 7 days post-procedure (whichever comes first)
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate | 0.4 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate or Greater | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate or Greater | 0.9 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild | 11.8 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - AR but Severity Not Evaluable | 4.9 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate | 0.9 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace/Trivial | 10.5 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - None | 73.1 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace or Greater | 26.9 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild | 4.2 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - None | 84.8 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild | 15.4 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace or Greater | 15.2 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - AR but Severity Not Evaluable | 1.4 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace/Trivial | 17.4 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - None | 64.9 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace or Greater | 35.1 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - AR but Severity Not Evaluable | 4.3 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate or Greater | 0.4 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace/Trivial | 6.1 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace/Trivial | 18.4 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace or Greater | 8.7 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - None | 91.3 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace/Trivial | 1.8 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild | 0.7 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild-Moderate | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate | 0.4 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate-Severe | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Severe | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate or Greater | 0.4 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - AR but Severity Not Evaluable | 5.8 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace or Greater | 72.6 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - None | 27.4 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace/Trivial | 18.1 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild | 46.9 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild-Moderate | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate | 3.6 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate-Severe | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Severe | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate or Greater | 3.6 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - AR but Severity Not Evaluable | 4.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace or Greater | 73.3 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - None | 26.7 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild | 48.7 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild-Moderate | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate | 4.3 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate-Severe | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Severe | 0.0 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate or Greater | 4.3 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - AR but Severity Not Evaluable | 1.8 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace/Trivial | 20.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild | 3.2 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - AR but Severity Not Evaluable | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild | 15.8 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - AR but Severity Not Evaluable | 3.2 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate or Greater | 1.1 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - None | 84.2 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace/Trivial | 6.3 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate | 1.1 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace or Greater | 28.4 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace or Greater | 36.8 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate | 1.1 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - None | 71.6 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - AR but Severity Not Evaluable | 5.3 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace/Trivial | 12.6 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - None | 63.2 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate or Greater | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild | 12.6 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate or Greater | 1.1 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace or Greater | 15.8 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate | 0.4 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate-Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - AR but Severity Not Evaluable | 1.1 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Moderate or Greater | 0.4 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - AR but Severity Not Evaluable | 6.9 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Severe | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace or Greater | 34.7 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace or Greater | 15.3 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - None | 65.3 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Mild | 4.7 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Trace/Trivial | 8.8 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild | 24.5 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Trace/Trivial | 4.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Mild-Moderate | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate or Greater | 0.4 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace or Greater | 28.5 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - AR but Severity Not Evaluable | 6.6 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - None | 71.5 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Total - Moderate | 0.4 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Trace/Trivial | 2.9 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Moderate or Greater | 0.0 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - None | 84.7 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Paravalvular - Mild | 18.2 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Each Grade of Aortic Valve Regurgitation in Each Location: Paravalvular, Central, and Combined | Central - Severe | 0.0 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure
Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Hear Association \[NYHA\] class III or IV)
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | Discharge | 0.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 30 Day | 1.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 6 Month | 6.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 1 Year | 11.2 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 30 Day | 3.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 6 Month | 9.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 1 Year | 13.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | Discharge | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 6 Month | 9.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 30 Day | 4.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 1 Year | 13.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | Discharge | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 1 Year | 9.6 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 30 Day | 2.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure | 6 Month | 6.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With Major Vascular Complication
Major vascular complication - including access site related and non access site related
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 1 Year Major Vascular Complications | 7.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 1 Year Not Access Site Related | 2.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 6 Month Access Site Related | 5.1 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | Discharge Access Site Related | 4.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 6 Month Not Access Site Related | 2.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | Discharge Not Access Site Related | 2.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 30 Day Major Vascular Complications | 7.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 1 Year Access Site Related | 5.1 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 30 Day Access Site Related | 4.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 30 Day Not Access Site Related | 2.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | Discharge Major Vascular Complications | 6.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Major Vascular Complication | 6 Month Major Vascular Complications | 7.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 1 Year Not Access Site Related | 2.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 6 Month Major Vascular Complications | 5.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 30 Day Major Vascular Complications | 5.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 6 Month Not Access Site Related | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | Discharge Access Site Related | 3.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 6 Month Access Site Related | 3.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 1 Year Major Vascular Complications | 6.1 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 30 Day Not Access Site Related | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 30 Day Access Site Related | 3.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | Discharge Not Access Site Related | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | Discharge Major Vascular Complications | 5.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Major Vascular Complication | 1 Year Access Site Related | 3.7 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 6 Month Access Site Related | 6.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | Discharge Major Vascular Complications | 8.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | Discharge Access Site Related | 6.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | Discharge Not Access Site Related | 2.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 30 Day Major Vascular Complications | 8.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 30 Day Access Site Related | 6.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 30 Day Not Access Site Related | 2.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 6 Month Major Vascular Complications | 8.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 6 Month Not Access Site Related | 2.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 1 Year Major Vascular Complications | 8.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 1 Year Access Site Related | 6.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Major Vascular Complication | 1 Year Not Access Site Related | 3.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 30 Day Not Access Site Related | 3.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 30 Day Access Site Related | 4.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | Discharge Major Vascular Complications | 7.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 1 Year Major Vascular Complications | 8.2 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 30 Day Major Vascular Complications | 7.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | Discharge Not Access Site Related | 3.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 1 Year Not Access Site Related | 3.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 1 Year Access Site Related | 4.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 6 Month Access Site Related | 4.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 6 Month Major Vascular Complications | 8.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | Discharge Access Site Related | 4.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Major Vascular Complication | 6 Month Not Access Site Related | 3.7 Percentage of participants |
Other Pre-specified
Percentage of Participants With Mitral Apparatus Damage
Mitral apparatus damage
Time frame: ≤72 hours post index procedure
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Mitral Apparatus Damage | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mitral Apparatus Damage | 0.3 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mitral Apparatus Damage | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mitral Apparatus Damage | 0.0 Percentage of participants |
Other Pre-specified
Percentage of Participants With Mortality
All-cause, Cardiovascular, and Non-cardiovascular
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat patients with mortality or who were event free with sufficient follow-up for the applicable time point (30 days - at least 23 days of follow-up; 6 months - at least 150 days of follow-up; 1 year - at least 335 days of follow-up).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 1 Year All Cause Mortality | 11.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 1 Year Non-Cardiovascular Mortality | 4.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 6 Month Cardiovascular Mortality | 5.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | Discharge All Cause Mortality | 1.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 6 Month Non-Cardiovascular Mortality | 2.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | Discharge Non-Cardiovascular Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 30 Day All Cause Mortality | 2.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | Discharge Cardiovascular Mortality | 1.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 1 Year Cardiovascular Mortality | 7.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 30 Day Cardiovascular Mortality | 2.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 30 Day Non-Cardiovascular Mortality | 0.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Mortality | 6 Month All Cause Mortality | 7.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | Discharge Cardiovascular Mortality | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 6 Month All Cause Mortality | 8.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 30 Day All Cause Mortality | 2.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 6 Month Non-Cardiovascular Mortality | 1.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 1 Year All Cause Mortality | 13.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 6 Month Cardiovascular Mortality | 6.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | Discharge All Cause Mortality | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 30 Day Non-Cardiovascular Mortality | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 30 Day Cardiovascular Mortality | 2.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | Discharge Non-Cardiovascular Mortality | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 1 Year Non-Cardiovascular Mortality | 3.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Mortality | 1 Year Cardiovascular Mortality | 9.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 6 Month Cardiovascular Mortality | 5.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | Discharge All Cause Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | Discharge Cardiovascular Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | Discharge Non-Cardiovascular Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 30 Day All Cause Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 30 Day Cardiovascular Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 30 Day Non-Cardiovascular Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 6 Month All Cause Mortality | 8.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 6 Month Non-Cardiovascular Mortality | 2.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 1 Year All Cause Mortality | 12.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 1 Year Cardiovascular Mortality | 7.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Mortality | 1 Year Non-Cardiovascular Mortality | 5.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 30 Day Non-Cardiovascular Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 30 Day Cardiovascular Mortality | 3.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | Discharge All Cause Mortality | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 1 Year All Cause Mortality | 9.2 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 30 Day All Cause Mortality | 3.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | Discharge Non-Cardiovascular Mortality | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 1 Year Non-Cardiovascular Mortality | 3.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 1 Year Cardiovascular Mortality | 5.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 6 Month Cardiovascular Mortality | 4.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 6 Month All Cause Mortality | 7.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | Discharge Cardiovascular Mortality | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Mortality | 6 Month Non-Cardiovascular Mortality | 2.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With Myocardial Infarction (MI)
Periprocedural (≤72 hours post index procedure) and spontaneous (\>72 hours post index procedure)
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | Discharge Myocardial Infarction | 0.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Myocardial Infarction | 3.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Peri-procedural MI | 0.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | Discharge Spontaneous MI | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Spontaneous MI | 1.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Spontaneous MI | 2.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Spontaneous MI | 0.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Myocardial Infarction | 0.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | Discharge Peri-procedural MI | 0.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Peri-procedural MI | 0.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Myocardial Infarction | 2.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Peri-procedural MI | 0.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Myocardial Infarction | 3.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Peri-procedural MI | 1.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | Discharge Myocardial Infarction | 1.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Myocardial Infarction | 4.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Spontaneous MI | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | Discharge Spontaneous MI | 0.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Myocardial Infarction | 1.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Spontaneous MI | 3.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Peri-procedural MI | 1.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Peri-procedural MI | 1.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Spontaneous MI | 0.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Myocardial Infarction (MI) | Discharge Peri-procedural MI | 1.3 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Myocardial Infarction | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | Discharge Myocardial Infarction | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | Discharge Peri-procedural MI | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Peri-procedural MI | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Spontaneous MI | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Myocardial Infarction | 2.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Peri-procedural MI | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Spontaneous MI | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Myocardial Infarction | 5.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Spontaneous MI | 3.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | Discharge Spontaneous MI | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Peri-procedural MI | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Spontaneous MI | 0.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Peri-procedural MI | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Peri-procedural MI | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 30 Day Myocardial Infarction | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | Discharge Peri-procedural MI | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Spontaneous MI | 3.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | Discharge Spontaneous MI | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | Discharge Myocardial Infarction | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Spontaneous MI | 3.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Peri-procedural MI | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 6 Month Myocardial Infarction | 3.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Myocardial Infarction (MI) | 1 Year Myocardial Infarction | 4.4 Percentage of participants |
Other Pre-specified
Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter
New onset of atrial fibrillation or atrial flutter
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | Discharge | 6.4 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 30 Day | 5.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 6 Month | 6.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 1 Year | 6.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 30 Day | 4.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 6 Month | 4.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 1 Year | 4.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | Discharge | 3.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 6 Month | 5.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 30 Day | 5.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 1 Year | 5.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | Discharge | 4.9 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 1 Year | 5.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 30 Day | 5.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | Discharge | 5.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Onset of Atrial Fibrillation or Atrial Flutter | 6 Month | 5.1 Percentage of participants |
Other Pre-specified
Percentage of Participants With New Permanent Pacemaker Implantation
New permanent pacemaker implantation resulting from new or worsened conduction disturbances
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | Discharge | 28.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | 30 Day | 29.1 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | 6 Month | 33.3 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | 1 Year | 34.2 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | 30 Day | 15.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | 6 Month | 18.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | 1 Year | 18.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With New Permanent Pacemaker Implantation | Discharge | 14.8 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | 6 Month | 29.4 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | 30 Day | 28.4 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | 1 Year | 30.7 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | Discharge | 27.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | 1 Year | 31.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | 30 Day | 28.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | Discharge | 24.1 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With New Permanent Pacemaker Implantation | 6 Month | 30.2 Percentage of participants |
Other Pre-specified
Percentage of Participants With Procedural Success
Defined as absence of procedural mortality, correct positioning of a single transcatheter valve into the proper anatomical location , intended performance of the study device (effective orifice area \[EOA\] \>0.9 cm2 for body surface area (BSA) \<1.6 m2 and EOA \>1.1 cm2 for BSA ≥1.6 m2 plus either a mean aortic valve gradient \<20 mm Hg or a peak velocity \<3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) plus no serious adverse events
Time frame: 30 days post procedure
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Procedural Success | 32.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Procedural Success | 39.2 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Procedural Success | 33.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Procedural Success | 29.3 Percentage of participants |
Other Pre-specified
Percentage of Participants With Prosthetic Aortic Valve Endocarditis
Prosthetic aortic valve endocarditis
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 30 Day | 0.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 6 Month | 0.5 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 1 Year | 0.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 30 Day | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 6 Month | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 1 Year | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 6 Month | 3.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 30 Day | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 1 Year | 4.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 1 Year | 0.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 30 Day | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Endocarditis | 6 Month | 0.3 Percentage of participants |
Other Pre-specified
Percentage of Participants With Prosthetic Aortic Valve Malpositioning
Prosthetic aortic valve malpositioning, including valve migration, valve embolization, or ectopic valve deployment
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Migration | 0.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Prosthetic aortic valve malpositioning | 2.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Ectopic Valve Deployment (Procedural) | 0.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Ectopic Valve Deployment (Procedural) | 0.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Embolization | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Migration | 0.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Embolization | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Embolization | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Prosthetic aortic valve malpositioning | 2.6 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Embolization | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Ectopic Valve Deployment (Procedural) | 0.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Migration | 0.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Prosthetic aortic valve malpositioning | 2.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Ectopic Valve Deployment (Procedural) | 0.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Migration | 0.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Prosthetic aortic valve malpositioning | 2.6 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 30 Day Valve Migration | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 1 Year Valve Embolization | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Prosthetic aortic valve malpositioning | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | Discharge Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Malpositioning | 6 Month Ectopic Valve Deployment (Procedural) | 0.0 Percentage of participants |
Other Pre-specified
Percentage of Participants With Prosthetic Aortic Valve Thrombosis
Prosthetic aortic valve thrombosis
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 30 Day | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 6 Month | 1.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 1 Year | 1.5 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 30 Day | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 6 Month | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 1 Year | 0.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 6 Month | 3.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 30 Day | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 1 Year | 6.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | Discharge | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 1 Year | 2.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 30 Day | 1.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | Discharge | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Prosthetic Aortic Valve Thrombosis | 6 Month | 2.0 Percentage of participants |
Other Pre-specified
Percentage of Participants With Repeat Procedure for Valve-related Dysfunction
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | Discharge Repeat proc valve-related dysfunction | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 30 Day Repeat proc valve-related dysfunction | 0.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 6 Month Repeat proc valve-related dysfunction | 0.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 1 Year Repeat proc valve-related dysfunction | 0.2 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 1 Year Repeat proc valve-related dysfunction | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 6 Month Repeat proc valve-related dysfunction | 1.7 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 30 Day Repeat proc valve-related dysfunction | 1.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | Discharge Repeat proc valve-related dysfunction | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 6 Month Repeat proc valve-related dysfunction | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 1 Year Repeat proc valve-related dysfunction | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 30 Day Repeat proc valve-related dysfunction | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | Discharge Repeat proc valve-related dysfunction | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 1 Year Repeat proc valve-related dysfunction | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | Discharge Repeat proc valve-related dysfunction | 0.3 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 30 Day Repeat proc valve-related dysfunction | 0.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Repeat Procedure for Valve-related Dysfunction | 6 Month Repeat proc valve-related dysfunction | 1.0 Percentage of participants |
Other Pre-specified
Percentage of Participants With Stroke
Disabling Stroke and Non-disabling Stroke
Time frame: assessed at discharge, 30 days, 6 months, and 1, 2, 3, 4, and 5 years post index procedure, at discharge, 30 days, 6 months, and 1 year post index procedure reported.
Population: Intent to Treat
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 6 Month All Stroke | 5.9 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 1 Year Non-Disabling Stroke | 3.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 1 Year All Stroke | 7.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 6 Month Disabling Stroke | 2.7 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | Discharge Non-Disabling Stroke | 2.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 6 Month Non-Disabling Stroke | 3.2 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | Discharge All Stroke | 4.4 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 30 Day All Stroke | 4.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | Discharge Disabling Stroke | 1.8 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 30 Day Disabling Stroke | 2.0 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 1 Year Disabling Stroke | 3.6 Percentage of participants |
| Lotus Valve System - Randomized | Percentage of Participants With Stroke | 30 Day Non-Disabling Stroke | 2.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | Discharge All Stroke | 4.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 6 Month All Stroke | 8.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 30 Day All Stroke | 4.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 1 Year All Stroke | 9.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 1 Year Disabling Stroke | 7.1 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 6 Month Disabling Stroke | 6.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 30 Day Non-Disabling Stroke | 1.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 30 Day Disabling Stroke | 3.3 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 6 Month Non-Disabling Stroke | 2.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | Discharge Non-Disabling Stroke | 1.0 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | 1 Year Non-Disabling Stroke | 2.4 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Stroke | Discharge Disabling Stroke | 3.3 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 1 Year Disabling Stroke | 5.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | Discharge All Stroke | 3.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | Discharge Disabling Stroke | 3.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | Discharge Non-Disabling Stroke | 0.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 30 Day All Stroke | 4.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 30 Day Disabling Stroke | 3.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 30 Day Non-Disabling Stroke | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 6 Month All Stroke | 6.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 6 Month Disabling Stroke | 5.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 6 Month Non-Disabling Stroke | 1.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 1 Year All Stroke | 7.9 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Stroke | 1 Year Non-Disabling Stroke | 2.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 30 Day Non-Disabling Stroke | 2.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 1 Year Non-Disabling Stroke | 2.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 1 Year All Stroke | 8.5 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 30 Day Disabling Stroke | 4.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 30 Day All Stroke | 6.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | Discharge Non-Disabling Stroke | 1.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 1 Year Disabling Stroke | 5.8 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | Discharge Disabling Stroke | 3.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | Discharge All Stroke | 5.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 6 Month Disabling Stroke | 5.4 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 6 Month Non-Disabling Stroke | 2.7 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Stroke | 6 Month All Stroke | 8.1 Percentage of participants |
Other Pre-specified
Percentage of Participants With Successful Deployment of the Study Valve
Successful deployment of the study valve
Time frame: at discharge or 7 days post-procedure (whichever comes first)
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Successful Deployment of the Study Valve | 97.8 Percentage of participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Successful Deployment of the Study Valve | 99.0 Percentage of participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Successful Deployment of the Study Valve | 99.0 Percentage of participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Successful Deployment of the Study Valve | 96.6 Percentage of participants |
Other Pre-specified
Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted
Successful repositioning of the study valve if repositioning is attempted
Time frame: at discharge or 7 days post-procedure (whichever comes first)
Population: Number of Intent to Treat participants who had Repositioning attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted | 100 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted | 100 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted | 100 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Successful Repositioning of the Study Valve if Repositioning is Attempted | 97.1 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted
Successful retrieval of the study valve if retrieval is attempted
Time frame: at discharge or 7 days post-procedure (whichever comes first)
Population: Number of Intent to Treat participants who had Retrieval attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted | 100 Percentage of Participants |
| CoreValve TAVR System - Randomized | Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted | 92.9 Percentage of Participants |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted | 100 Percentage of Participants |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Successful Retrieval of the Study Valve if Retrieval is Attempted | 100 Percentage of Participants |
Other Pre-specified
Percentage of Participants With Ventricular Septal Perforation
Ventricular septal perforation
Time frame: ≤72 hours post index procedure
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lotus Valve System - Randomized | Percentage of Participants With Ventricular Septal Perforation | 0.2 Percentage of participant |
| CoreValve TAVR System - Randomized | Percentage of Participants With Ventricular Septal Perforation | 0.0 Percentage of participant |
| Lotus Valve System - Single-arm Roll-in Cohort | Percentage of Participants With Ventricular Septal Perforation | 0.0 Percentage of participant |
| Lotus Valve System - Single-arm Continued Access Cohort | Percentage of Participants With Ventricular Septal Perforation | 0.0 Percentage of participant |