Aortic Stenosis
Conditions
Brief summary
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR. As of 28-May-2025, Boston Scientific Corporation (BSC) announced the voluntary global discontinuation of the ACURATE product platform, including both the ACURATE neo2 and ACURATE Prime Aortic Valve Systems. BSC will no longer pursue regulatory approval for the device in the U.S. or other unapproved geographies.
Detailed description
Subjects will be enrolled at up to 85 centers in the United States, Canada, Europe, and Australia. There will be up to 2,820 subjects in ACURATE IDE. The ACURATE IDE study cohorts include the following. * Main Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT; ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration \[SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA\] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration \[CoreValve; Medtronic, Inc., Dublin, Ireland\]). There will be up to 1,500 subjects in the RCT. * Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery; Boston Scientific Corporation, Marlborough, MA, USA) will perform at least 2 roll-in cases before commencing treatment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis. * 4D CT Imaging Substudy: Selected centers with the ability to perform high quality 4D computer tomography (CT) scans will include subjects in a 4D CT Imaging Substudy to assess the prevalence of reduced leaflet mobility and hypoattenuated leaflet thickening (HALT) and the relationship, if any, to clinical events. Subjects will be randomized to test (ACURATE) and control device. * ACURATE Prime™ XL Nested Registry: A non-randomized, nested registry cohort of subjects who will receive the ACURATE Prime™ Transfemoral Aortic Valve System XL (ACURATE Prime XL Nested Registry). Participating centers will be a subset of United States centers that have enrolled subjects in ACURATE IDE. Data from subjects in this nested registry will be summarized separately from the randomized and roll-in cohorts. * ACURATE Extended Durability Study: An additional 1:1 randomized study (ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration \[SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA\] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration \[CoreValve; Medtronic, Inc., Dublin, Ireland\]) including only subjects considered to be at low surgical risk. Subjects will receive ACURATE neo2 (S, M, or L valve sizes) or ACURATE Prime XL. Data from subjects in the Extended Durability Study will be summarized separately from other cohorts. * ACURATE Continued Access Study (CAS): An additional cohort of subjects receiving ACURATE neo2 (S, M, and L valve sizes) or ACURATE Prime XL. Data from subjects in the ACURATE CAS will be summarized separately from other cohorts and will be used to further assess performance and safety. Follow-up * Subjects implanted with a test device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, 1 year, and then annually for 5 years post-procedure. * Subjects implanted with a control device will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post procedure (whichever comes first), 30 days, 6 months, and 1 year post procedure. Per protocol, no additional follow-up is required beyond this period, and standard of care practices will apply. * Some subjects may have completed additional annual follow-up visits based on requirements outlined in earlier versions of the protocol. * Subjects who are enrolled but not implanted with a test or control device at the time of the procedure will be followed for safety through 1 year.
Interventions
DEVICEACURATE neo2™ Transfemoral TAVR System
ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
DEVICEMedtronic CoreValve TAVR System
Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).
DEVICEEdwards SAPIEN 3 TAVR System
Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)
DEVICEACURATE Prime™ Transfemoral TAVR System XL
ACURATE Prime™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
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
* IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/s, OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction \<50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be enrolled if echocardiographic criteria are met with this augmentation. * IC2. Subject has a documented aortic annulus size of ≥20.5 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 Main Randomized Cohort and the Extended Durability Study, is deemed treatable with an available size of both test and control device. * IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II. * IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is indicated for TAVR, is likely to benefit from valve replacement, and TAVR is appropriate. * IC5. Subject (or legal representative) understands the study requirements and the treatment procedures, and provides written informed consent. * IC6. 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. * IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.
Exclusion criteria
* EC1. Subject has a unicuspid or bicuspid aortic valve. * EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation). * EC3. Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment. * EC4. Subject is on renal replacement therapy or has eGFR \<20. * EC5. Subject has a pre-existing prosthetic aortic or mitral valve. * EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation. * EC7. Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D76). * EC8. Subject has a need for emergency surgery for any reason. * EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis. * EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention. * EC11. Subject has platelet count \<50,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<1,000 cells/mm3. * EC12. 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. * EC13. Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated, or has known hypersensitivity to the protocol required medications (aspirin, all P2Y12 inhibitors, heparin), or to the individual components of the test or control valve (nickel, titanium, stainless steel, platinum, iridium or polyethylene terephthalate \[PET\]). * EC14. 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. * EC15. Subject has hypertrophic cardiomyopathy. * EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed). * EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization. * EC18. Subject has severe left ventricular dysfunction with ejection fraction \<20%. * EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices. * EC20. Subject has arterial access that is not acceptable for the study device (test or control) delivery systems as defined in the device (test or control) Directions For Use. * EC21. Subject has either of the following: * 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 thick, protruding, ulcerated atheroma in the aortic arch), OR * Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVR prosthesis. * EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study. * EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after index procedure. * EC24. 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. * EC25. Subject has severe incapacitating dementia. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort. | Participants will be followed for the duration of hospital stay through 1 year. | Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORRaj R. Makkar, MD
Cedars-Sinai Heart Institute
PRINCIPAL_INVESTIGATORMichael J. Reardon, MD
Methodist DeBakey Heart & Vascular Center
Participant flow
Recruitment details
Main Randomized Cohort: 1500 subjects randomized from 10Jun2019 to 19Apr2023. Roll-in Cohort: 148 subjects enrolled from 10Jul2019 to 27Feb2023.
Pre-assignment details
The non-randomized Roll-in phase with only the test device was for centers with no previous experience implanting ACURATE. Each applicable site performed at least two Roll-in cases before starting enrollment in the Main Randomized Cohort. Only data for the Main Randomized Cohort and Roll-in Cohort are being reported up to 1 year (Primary Endpoint).
Participants by arm
| Arm | Count |
|---|---|
| ACURATE neo2 Valve - Main Randomized Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System.
\*A subset of subjects will also be enrolled in the 4D CT Imaging Substudy. | 752 |
| Commercial Valve - Main Randomized Medtronic CoreValve TAVR System OR,Edwards SAPIEN 3 TAVR System
Patients assigned to this group will be implanted with commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration (SAPIEN 3; Edwards Lifesciences LLC, Irvine, CA, USA) or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration (CoreValve; Medtronic, Inc., Dublin, Ireland) TAVR device.
\*A minimum of 200 subjects will also be enrolled in the 4D CT Imaging Substudy. | 748 |
| ACURATE neo2 Valve - Single-arm Roll-in Patients assigned to this group will be implanted with ACURATE neo2™ transfemoral TAVR System. | 148 |
| Total | 1,648 |
Baseline characteristics
| Characteristic | ACURATE neo2 Valve - Main Randomized | Commercial Valve - Main Randomized | ACURATE neo2 Valve - Single-arm Roll-in | Total |
|---|---|---|---|---|
| Age, Continuous | 78.0 Years STANDARD_DEVIATION 6.9 | 79.0 Years STANDARD_DEVIATION 6.5 | 78.8 Years STANDARD_DEVIATION 7.1 | 78.5 Years STANDARD_DEVIATION 6.8 |
| Aortic Annulus Area | 435.2 mm2 STANDARD_DEVIATION 58.7 | 437.3 mm2 STANDARD_DEVIATION 54.7 | 439.6 mm2 STANDARD_DEVIATION 56.6 | 436.5 mm2 STANDARD_DEVIATION 56.7 |
| Aortic Annulus Perimeter | 74.8 mm STANDARD_DEVIATION 5 | 75.1 mm STANDARD_DEVIATION 4.6 | 75.2 mm STANDARD_DEVIATION 4.9 | 75.0 mm STANDARD_DEVIATION 4.8 |
| Aortic Valve Area (AVA) | 0.67 cm2 STANDARD_DEVIATION 0.14 | 0.67 cm2 STANDARD_DEVIATION 0.15 | 0.71 cm2 STANDARD_DEVIATION 0.17 | 0.68 cm2 STANDARD_DEVIATION 0.15 |
| Aortic Valve Mean Pressure Gradient | 39.6 mmHg STANDARD_DEVIATION 11.1 | 39.4 mmHg STANDARD_DEVIATION 10.5 | 38.7 mmHg STANDARD_DEVIATION 12 | 39.4 mmHg STANDARD_DEVIATION 10.9 |
| Aortic Valve Peak Velocity | 4.05 m/s STANDARD_DEVIATION 0.54 | 4.04 m/s STANDARD_DEVIATION 0.51 | 3.99 m/s STANDARD_DEVIATION 0.57 | 4.04 m/s STANDARD_DEVIATION 0.53 |
| Body Mass Index (BMI) | 30.6 kg/m2 STANDARD_DEVIATION 6.5 | 29.8 kg/m2 STANDARD_DEVIATION 6.1 | 31.5 kg/m2 STANDARD_DEVIATION 7.8 | 30.3 kg/m2 STANDARD_DEVIATION 6.5 |
| Doppler Velocity Index (DVI) | 0.24 Index STANDARD_DEVIATION 0.05 | 0.24 Index STANDARD_DEVIATION 0.05 | 0.24 Index STANDARD_DEVIATION 0.06 | 0.24 Index STANDARD_DEVIATION 0.05 |
| Medical History Current diabetes mellitus | 37.2 Percentage of participants | 36.2 Percentage of participants | 42.6 Percentage of participants | 37.3 Percentage of participants |
| Medical History History of atrial fibrillation/atrial flutter | 24.1 Percentage of participants | 23.4 Percentage of participants | 34.5 Percentage of participants | 24.7 Percentage of participants |
| Medical History History of cerebrovascular accident (TIA & stroke) | 13.0 Percentage of participants | 11.5 Percentage of participants | 12.2 Percentage of participants | 12.3 Percentage of participants |
| Medical History History of congestive heart failure | 31.6 Percentage of participants | 35.0 Percentage of participants | 47.3 Percentage of participants | 34.6 Percentage of participants |
| Medical History History of coronary artery disease | 52.1 Percentage of participants | 52.9 Percentage of participants | 58.1 Percentage of participants | 53.0 Percentage of participants |
| Medical History History of hypertension | 89.4 Percentage of participants | 88.0 Percentage of participants | 91.2 Percentage of participants | 88.9 Percentage of participants |
| Medical History History of myocardial infarction | 8.6 Percentage of participants | 7.8 Percentage of participants | 10.8 Percentage of participants | 8.4 Percentage of participants |
| Medical History Prior pacemaker implant | 6.4 Percentage of participants | 7.0 Percentage of participants | 11.5 Percentage of participants | 7.1 Percentage of participants |
| New York Heart Association (NYHA) Classification Class I | 0.0 Percentage of participants | 0.0 Percentage of participants | 0.0 Percentage of participants | 0.0 Percentage of participants |
| New York Heart Association (NYHA) Classification Class II | 50.7 Percentage of participants | 57.8 Percentage of participants | 54.7 Percentage of participants | 54.2 Percentage of participants |
| New York Heart Association (NYHA) Classification Class III | 47.3 Percentage of participants | 40.4 Percentage of participants | 43.9 Percentage of participants | 43.9 Percentage of participants |
| New York Heart Association (NYHA) Classification Class IV | 2.0 Percentage of participants | 1.9 Percentage of participants | 1.4 Percentage of participants | 1.9 Percentage of participants |
| Operative Risk Group High/Extreme | 25.5 Percentage of participants | 28.6 Percentage of participants | 33.8 Percentage of participants | 27.7 Percentage of participants |
| Operative Risk Group Intermediate | 38.6 Percentage of participants | 36.9 Percentage of participants | 52.7 Percentage of participants | 39.1 Percentage of participants |
| Operative Risk Group Low | 35.9 Percentage of participants | 34.5 Percentage of participants | 13.5 Percentage of participants | 33.3 Percentage of participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 13 Participants | 1 Participants | 20 Participants |
| Race/Ethnicity, Customized Asian - Chinese | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - Japanese | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - Korean | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 29 Participants | 23 Participants | 3 Participants | 55 Participants |
| Race/Ethnicity, Customized Caucasian | 675 Participants | 659 Participants | 137 Participants | 1471 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 24 Participants | 27 Participants | 3 Participants | 54 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Disclosed | 5 Participants | 14 Participants | 1 Participants | 20 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 11 Participants | 2 Participants | 26 Participants |
| Race/Ethnicity, Customized Other Asian | 3 Participants | 9 Participants | 0 Participants | 12 Participants |
| Region of Enrollment Canada | 59 participants | 61 participants | 0 participants | 120 participants |
| Region of Enrollment United States | 693 participants | 687 participants | 148 participants | 1528 participants |
| Sex/Gender, Customized Female | 395 Participants | 383 Participants | 84 Participants | 862 Participants |
| Sex/Gender, Customized Intersex | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Male | 357 Participants | 364 Participants | 64 Participants | 785 Participants |
| Sex/Gender, Customized Unknown | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Society of Thoracic Surgeons (STS) Risk Score | 2.7 Percent STANDARD_DEVIATION 1.8 | 2.8 Percent STANDARD_DEVIATION 1.9 | 3.5 Percent STANDARD_DEVIATION 2.3 | 2.8 Percent STANDARD_DEVIATION 1.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 36 / 752 | 28 / 748 | 7 / 148 |
| other Total, other adverse events | 155 / 752 | 145 / 748 | 26 / 148 |
| serious Total, serious adverse events | 389 / 752 | 381 / 748 | 81 / 148 |
Outcome results
Primary
Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort.
Primary Endpoint: A Clinical Events Committee (CEC), independent group of physician experts reviewed and adjudicated all reported cases of death, stroke and rehospitalization to determine whether they met the specific protocol definition of the event. The CEC adjudicated results are used in the endpoint analysis. \* Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV); per VARC-2 definition.
Time frame: Participants will be followed for the duration of hospital stay through 1 year.
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort. | 16.16 percentage of participants |
| Commercial Valve - Main Randomized | Composite Rate of All-cause Mortality, All Stroke, and Rehospitalization* at 1 Year in the Main Randomized Cohort. | 9.53 percentage of participants |
Other Pre-specified
Effective Orifice Area (EOA)
Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory
Time frame: Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.~Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Effective Orifice Area (EOA) | Discharge/7 Days Post-Procedure | 1.77 cm2 | Standard Deviation 0.3 |
| ACURATE neo2 Valve - Main Randomized | Effective Orifice Area (EOA) | 1 Year Post-Procedure | 1.77 cm2 | Standard Deviation 0.28 |
| ACURATE neo2 Valve - Main Randomized | Effective Orifice Area (EOA) | 6 Months Post-Procedure | 1.76 cm2 | Standard Deviation 0.28 |
| ACURATE neo2 Valve - Main Randomized | Effective Orifice Area (EOA) | 30 Days Post-Procedure | 1.76 cm2 | Standard Deviation 0.29 |
| Commercial Valve - Main Randomized | Effective Orifice Area (EOA) | 6 Months Post-Procedure | 1.77 cm2 | Standard Deviation 0.31 |
| Commercial Valve - Main Randomized | Effective Orifice Area (EOA) | 30 Days Post-Procedure | 1.78 cm2 | Standard Deviation 0.31 |
| Commercial Valve - Main Randomized | Effective Orifice Area (EOA) | 1 Year Post-Procedure | 1.78 cm2 | Standard Deviation 0.3 |
| Commercial Valve - Main Randomized | Effective Orifice Area (EOA) | Discharge/7 Days Post-Procedure | 1.82 cm2 | Standard Deviation 32 |
| ACURATE neo2 Valve - Single-arm Roll-in | Effective Orifice Area (EOA) | 1 Year Post-Procedure | 1.64 cm2 | Standard Deviation 0.32 |
| ACURATE neo2 Valve - Single-arm Roll-in | Effective Orifice Area (EOA) | Discharge/7 Days Post-Procedure | 1.68 cm2 | Standard Deviation 0.34 |
| ACURATE neo2 Valve - Single-arm Roll-in | Effective Orifice Area (EOA) | 30 Days Post-Procedure | 1.65 cm2 | Standard Deviation 0.34 |
| ACURATE neo2 Valve - Single-arm Roll-in | Effective Orifice Area (EOA) | 6 Months Post-Procedure | 1.65 cm2 | Standard Deviation 0.31 |
Other Pre-specified
Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment)
Grade of Aortic Regurgitation as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
Time frame: Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace | 57.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild | 23.9 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate | 1.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace | 98.8 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild | 1.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - None/Trace | 75.9 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Mild | 23.0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Moderate | 1.0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Severe | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace | 74.9 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Mild | 38.6 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate | 4.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Severe | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace | 97.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Mild | 2.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - None/Trace | 58.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Mild | 38.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Moderate | 3.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Severe | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace | 53.0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Mild | 41.8 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate | 5.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Severe | 0.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace | 96.6 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Mild | 3.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate | 0.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - None/Trace | 54.6 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Mild | 40.8 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Moderate | 4.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Severe | 0.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace | 52.6 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Mild | 42.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate | 4.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Severe | 0.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace | 95.0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Mild | 4.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate | 0.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - None/Trace | 55.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Mild | 40.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Moderate | 3.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Severe | 0.5 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Mild | 24.8 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace | 99.9 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Mild | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate | 1.8 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - None/Trace | 75.8 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Mild | 23.2 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Moderate | 1.0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Mild | 24.2 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace | 70.1 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace | 99.4 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Mild | 29.2 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate | 0.8 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Mild | 0.6 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace | 99.0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Mild | 1.0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace | 85.9 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - None/Trace | 71.0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild | 13.8 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate | 0.3 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Moderate | 1.8 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Mild | 28.2 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace | 99.9 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Moderate | 0.8 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - None/Trace | 86.1 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Mild | 13.6 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Moderate | 0.3 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Severe | 0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace | 75.5 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace | 73.4 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Mild | 23.5 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate | 1.0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - None/Trace | 74.0 percentage of participants |
| Commercial Valve - Main Randomized | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Moderate | 4.3 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace | 97.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Mild | 32.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace | 68.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Mild | 2.9 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - None/Trace | 66.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace | 64.2 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - None/Trace | 70.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild | 29.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 30 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Moderate | 3.3 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - None/Trace | 58.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - None/Trace | 54.3 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Mild | 42.8 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate | 2.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - None/Trace | 52.2 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Moderate | 2.9 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 1 Year Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Mild | 28.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 30 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace | 57.3 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Moderate | 2.9 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - None/Trace | 97.3 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Mild | 38.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - None/Trace | 95.9 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Mild | 37.6 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate | 4.3 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Mild | 30.9 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Moderate | 1.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 6 Months Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Mild | 2.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 6 Months Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - None/Trace | 96.6 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 1 Year Post-Procedure - Mild | 4.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Total aortic regurgitation (AR) at 30 Days Post-Procedure - Mild | 44.9 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Mild | 3.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Moderate | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at Discharge/7 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Moderate | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Aortic paravalvular regurgitation (PVL) at 1 Year Post-Procedure - Moderate | 2.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at Discharge/7 Days Post-Procedure - Severe | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Grade of Aortic Valve Regurgitation: Paravalvular, Central and Combined (Echocardiographic Assessment) | Central aortic regurgitation (AR) at 6 Months Post-Procedure - Severe | 0 percentage of participants |
Other Pre-specified
Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline
Health Status additional outcome KCCQ Analysis - Overall Summary Score change from Baseline. 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. Overall Summary Score - mean of score 1, 5, 7, and 8
Time frame: Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.~Note: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Change from Baseline to 30 Days - Overall Summary Score | 18.1 Score on a scale | Standard Deviation 21.6 |
| ACURATE neo2 Valve - Main Randomized | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Baseline - Overall Summary Score | 62.4 Score on a scale | Standard Deviation 22.3 |
| ACURATE neo2 Valve - Main Randomized | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Change from Baseline to 1 Year - Overall Summary Score | 19.4 Score on a scale | Standard Deviation 22.2 |
| Commercial Valve - Main Randomized | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Change from Baseline to 30 Days - Overall Summary Score | 17.8 Score on a scale | Standard Deviation 22.1 |
| Commercial Valve - Main Randomized | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Baseline - Overall Summary Score | 62.2 Score on a scale | Standard Deviation 21.9 |
| Commercial Valve - Main Randomized | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Change from Baseline to 1 Year - Overall Summary Score | 20.0 Score on a scale | Standard Deviation 22.1 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Baseline - Overall Summary Score | 62.0 Score on a scale | Standard Deviation 21.5 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Change from Baseline to 1 Year - Overall Summary Score | 19.8 Score on a scale | Standard Deviation 20.8 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life Assessment - Change From Baseline | Change from Baseline to 30 Days - Overall Summary Score | 19.8 Score on a scale | Standard Deviation 21.1 |
Other Pre-specified
Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline
Health Status outcome - SF-12 - Baseline scores and changes from Baseline at 30 Days and 1 Year. 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.
Time frame: Participants will be assessed at baseline, 30 Days, and 1 Year. Data for 5 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.~Note: paired analysis includes subjects with non-missing data at both baseline and the specific follow-up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Baseline - Physical Summary Score | 36.9 Score on a scale | Standard Deviation 10.7 |
| ACURATE neo2 Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Baseline - Mental Health Summary Score | 51.7 Score on a scale | Standard Deviation 10 |
| ACURATE neo2 Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 30 Days - Physical Summary Score | 4.8 Score on a scale | Standard Deviation 9.9 |
| ACURATE neo2 Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 30 Days - Mental Health Summary Score | 2.8 Score on a scale | Standard Deviation 11.1 |
| ACURATE neo2 Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 1 Year - Physical Summary Score | 5.2 Score on a scale | Standard Deviation 11 |
| ACURATE neo2 Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 1 Year - Mental Health Summary Score | 2.0 Score on a scale | Standard Deviation 10.8 |
| Commercial Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 1 Year - Mental Health Summary Score | 2.1 Score on a scale | Standard Deviation 11.1 |
| Commercial Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Baseline - Physical Summary Score | 36.1 Score on a scale | Standard Deviation 11 |
| Commercial Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 30 Days - Mental Health Summary Score | 2.3 Score on a scale | Standard Deviation 11.1 |
| Commercial Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 1 Year - Physical Summary Score | 5.4 Score on a scale | Standard Deviation 11.5 |
| Commercial Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Baseline - Mental Health Summary Score | 51.8 Score on a scale | Standard Deviation 10.3 |
| Commercial Valve - Main Randomized | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 30 Days - Physical Summary Score | 5.4 Score on a scale | Standard Deviation 10.5 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Baseline - Mental Health Summary Score | 51.6 Score on a scale | Standard Deviation 9.1 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 30 Days - Physical Summary Score | 5.7 Score on a scale | Standard Deviation 10.6 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 1 Year - Mental Health Summary Score | 1.6 Score on a scale | Standard Deviation 10.4 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 30 Days - Mental Health Summary Score | 3.2 Score on a scale | Standard Deviation 10.7 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Baseline - Physical Summary Score | 36.4 Score on a scale | Standard Deviation 10.2 |
| ACURATE neo2 Valve - Single-arm Roll-in | Health Status: SF-12 Quality of Life Questionnaire Assessment - Change From Baseline | Change from Baseline to 1 Year - Physical Summary Score | 4.8 Score on a scale | Standard Deviation 10.2 |
Other Pre-specified
Mean Aortic Gradient
Mean Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.
Time frame: Participants will be assessed pre-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.~Number analyzed participants is based on central echo core lab data. Blank data fields or data recorded in the clinical database as 'Not evaluable' are considered missing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Mean Aortic Gradient | 30 Days Post-Procedure | 8 mmHg | Standard Deviation 3.2 |
| ACURATE neo2 Valve - Main Randomized | Mean Aortic Gradient | Discharge/7 Days Post-Procedure | 9.0 mmHg | Standard Deviation 3.9 |
| ACURATE neo2 Valve - Main Randomized | Mean Aortic Gradient | 6 Months Post-Procedure | 8.1 mmHg | Standard Deviation 3.3 |
| ACURATE neo2 Valve - Main Randomized | Mean Aortic Gradient | 1 Year Post-Procedure | 7.9 mmHg | Standard Deviation 3.3 |
| Commercial Valve - Main Randomized | Mean Aortic Gradient | 1 Year Post-Procedure | 10.7 mmHg | Standard Deviation 5 |
| Commercial Valve - Main Randomized | Mean Aortic Gradient | Discharge/7 Days Post-Procedure | 10.2 mmHg | Standard Deviation 4.2 |
| Commercial Valve - Main Randomized | Mean Aortic Gradient | 30 Days Post-Procedure | 10.1 mmHg | Standard Deviation 4.7 |
| Commercial Valve - Main Randomized | Mean Aortic Gradient | 6 Months Post-Procedure | 10.6 mmHg | Standard Deviation 5.1 |
| ACURATE neo2 Valve - Single-arm Roll-in | Mean Aortic Gradient | 1 Year Post-Procedure | 8.4 mmHg | Standard Deviation 3.4 |
| ACURATE neo2 Valve - Single-arm Roll-in | Mean Aortic Gradient | 6 Months Post-Procedure | 8.1 mmHg | Standard Deviation 4 |
| ACURATE neo2 Valve - Single-arm Roll-in | Mean Aortic Gradient | Discharge/7 Days Post-Procedure | 10.0 mmHg | Standard Deviation 4.7 |
| ACURATE neo2 Valve - Single-arm Roll-in | Mean Aortic Gradient | 30 Days Post-Procedure | 8.1 mmHg | Standard Deviation 3.3 |
Other Pre-specified
New York Heart Association (NYHA) Functional Status Classification
Health status evaluated by New York Heart Association (NYHA) Classification. NYHA Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years, 7 years, and 10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.~NYHA class denominator is the number of subjects with non-missing NYHA class at the studied timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - I | 57.7 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - II | 49.4 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - III | 15.8 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - IV | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post Procedure NYHA Functional Class - I | 34.1 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - II | 37.8 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - III | 4.3 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - IV | 0.3 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - I | 65.1 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - II | 29.9 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - III | 4.6 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - IV | 0.5 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - I | 64.9 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - II | 31.9 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - III | 3.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - IV | 0.2 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - II | 35.0 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - III | 4.9 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - IV | 0.0 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - II | 31.1 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - I | 66.2 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - II | 29.3 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - IV | 0.0 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - III | 4.4 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post Procedure NYHA Functional Class - I | 32.0 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - III | 4.4 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - II | 52.4 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - IV | 0.0 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - III | 15.5 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - IV | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - I | 60.1 Percentage of participants |
| Commercial Valve - Main Randomized | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - I | 64.4 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - III | 4.5 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - II | 39.3 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - I | 60.3 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - III | 18.4 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - III | 3.4 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - IV | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post Procedure NYHA Functional Class - I | 32.7 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - IV | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - IV | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 30 Days Post-Procedure NYHA Functional Class - I | 57.2 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - I | 64.4 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - II | 35.7 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - II | 49.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 6 Months Post-Procedure NYHA Functional Class - II | 31.1 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | Discharge/7 Days Post-Procedure NYHA Functional Class - IV | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | New York Heart Association (NYHA) Functional Status Classification | 1 Year Post-Procedure NYHA Functional Class - III | 4.0 Percentage of participants |
Other Pre-specified
Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, through 7 days post index procedure.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 2 | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) or Stage 2 | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 2 | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) or Stage 2 | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) or Stage 2 | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 3 (including renal replacement therapy) | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Acute Kidney Injury (AKI; ≤7 Days Post Index Procedure): Based on the AKIN System Stage 3 (Including Renal Replacement Therapy) or Stage 2 | Acute kidney injury based on AKIN System Stage 2 | 0 percentage of participants |
Other Pre-specified
Rate of All Stroke: Disabling and Non-disabling
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at Discharge/7 Days Post-Randomization | 0.9 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at Discharge/7 Days Post-Randomization | 0.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at 30 Days Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 30 Days Post-Randomization | 0.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 30 Days Post-Randomization | 1.0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at 6 Months Post-Randomization | 4.0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 6 Months Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 6 Months Post-Randomization | 2.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at 1 Year Post-Randomization | 5.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 1 Year Post-Randomization | 1.9 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 1 Year Post-Randomization | 3.9 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 1 Year Post-Randomization | 2.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at Discharge/7 Days Post-Randomization | 1.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at 6 Months Post-Randomization | 2.5 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 6 Months Post-Randomization | 1.5 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 30 Days Post-Randomization | 0.5 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 1 Year Post-Randomization | 1.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at Discharge/7 Days Post-Randomization | 0.4 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 6 Months Post-Randomization | 1.0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 30 Days Post-Randomization | 0.8 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at 30 Days Post-Randomization | 1.4 percentage of participants |
| Commercial Valve - Main Randomized | Rate of All Stroke: Disabling and Non-disabling | All stroke at 1 Year Post-Randomization | 3.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | All stroke at 30 Days Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 30 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | All stroke at 1 Year Post-Randomization | 7.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 30 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | All stroke at 6 Months Post-Randomization | 5.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 6 Months Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at 1 Year Post-Randomization | 2.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | All stroke at Discharge/7 Days Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Disabling stroke at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 6 Months Post-Randomization | 4.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of All Stroke: Disabling and Non-disabling | Non-disabling stroke at 1 Year Post-Randomization | 5.5 percentage of participants |
Other Pre-specified
Rate of Bleeding: Life-threatening (or Disabling) and Major
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at Discharge/7 Days Post-Randomization | 1.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at Discharge/7 Days Post-Randomization | 1.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 30 Days Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 30 Days Post-Randomization | 1.6 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 6 Months Post-Randomization | 2.9 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 6 Months Post-Randomization | 2.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 1 Year Post-Randomization | 3.6 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 1 Year Post-Randomization | 2.9 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 30 Days Post-Randomization | 1.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 1 Year Post-Randomization | 3.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 30 Days Post-Randomization | 1.4 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 6 Months Post-Randomization | 2.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 6 Months Post-Randomization | 2.6 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at Discharge/7 Days Post-Randomization | 1.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at Discharge/7 Days Post-Randomization | 1.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 1 Year Post-Randomization | 3.3 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 30 Days Post-Randomization | 2.0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at Discharge/7 Days Post-Randomization | 2.0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 30 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 1 Year Post-Randomization | 2.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 6 Months Post-Randomization | 2.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Life-threatening or disabling bleeding at 6 Months Post-Randomization | 2.0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Bleeding: Life-threatening (or Disabling) and Major | Major bleeding at 1 Year Post-Randomization | 3.4 percentage of participants |
Other Pre-specified
Rate of Cardiac Tamponade: Periprocedural
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed through 72 hours post index procedure
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Cardiac Tamponade: Periprocedural | 0.4 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Cardiac Tamponade: Periprocedural | 0.3 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Cardiac Tamponade: Periprocedural | 0.7 Percentage of participants |
Other Pre-specified
Rate of Coronary Obstruction: Periprocedural
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) - based on VARC endpoints and definitions.
Time frame: Participants will be followed through 72 hours post index procedure
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Coronary Obstruction: Periprocedural | 0.4 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Coronary Obstruction: Periprocedural | 0.3 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Coronary Obstruction: Periprocedural | 0.7 Percentage of participants |
Other Pre-specified
Rate of Device Success
Absence of procedural mortality, correct positioning of a single transcatheter valve in the proper anatomical location, and intended performance of the study device (indexed effective orifice area \[iEOA\] \>0.85 cm2/m2 for BMI \<30 kg/cm2 and iEOA \>0.70 cm2/m2 for BMI ≥30 kg/cm2 plus either a mean aortic valve gradient \<20 mmHg or a peak velocity \< 3m, and no moderate or severe prosthetic valve aortic regurgitation) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed for the duration of their procedure, an expected average of 1 Day (post-procedure)
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Device Success | iEOA >0.85 cm2/m2 for BMI <30 kg/m2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/m2 (AND) | 77.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Device Success | Absence of procedural mortality | 99.6 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Device Success | No moderate or severe prosthetic valve aortic regurgitation | 98.8 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Device Success | Mean aortic valve gradient <20 mmHg OR peak velocity <3m/sec (AND) | 99.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Device Success | Intended performance of the study device | 75.8 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Device Success | Correct positioning of a single valve into the proper anatomical location | 98.4 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Device Success | Device Success | 74.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Device Success | Absence of procedural mortality | 100.0 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Device Success | Correct positioning of a single valve into the proper anatomical location | 99.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Device Success | Intended performance of the study device | 82.5 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Device Success | iEOA >0.85 cm2/m2 for BMI <30 kg/m2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/m2 (AND) | 83.7 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Device Success | Mean aortic valve gradient <20 mmHg OR peak velocity <3m/sec (AND) | 98.3 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Device Success | No moderate or severe prosthetic valve aortic regurgitation | 99.7 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Device Success | Device Success | 81.8 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Device Success | Correct positioning of a single valve into the proper anatomical location | 100.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Device Success | No moderate or severe prosthetic valve aortic regurgitation | 97.9 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Device Success | Intended performance of the study device | 57.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Device Success | Absence of procedural mortality | 100.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Device Success | Device Success | 57.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Device Success | Mean aortic valve gradient <20 mmHg OR peak velocity <3m/sec (AND) | 96.5 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Device Success | iEOA >0.85 cm2/m2 for BMI <30 kg/m2 and iEOA >0.70 cm2/m2 for BMI ≥30 kg/m2 (AND) | 60.4 Percentage of participants |
Other Pre-specified
Rate of Ectopic Valve Deployment
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure through discharge or 7 days post-procedure (whichever comes first).
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Ectopic Valve Deployment | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Ectopic Valve Deployment | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Ectopic Valve Deployment | 0.0 Percentage of participants |
Other Pre-specified
Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV)
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 30 Days Post-Randomization | 0.8 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 6 Months Post-Randomization | 3.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 1 Year Post-Randomization | 5.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 1 Year Post-Randomization | 3.5 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 6 Months Post-Randomization | 1.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 30 Days Post-Randomization | 0.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 1 Year Post-Randomization | 4.8 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 30 Days Post-Randomization | 3.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | 6 Months Post-Randomization | 4.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Hospitalization for Valve-related Symptoms or Worsening Congestive Heart Failure (NYHA Class III or IV) | Discharge/7 Days Post-Randomization | 0 percentage of participants |
Other Pre-specified
Rate of Major Vascular Complications
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-5 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Major Vascular Complications | Discharge/7 Days Post-Randomization | 2.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Major Vascular Complications | 30 Days Post-Randomization | 2.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Major Vascular Complications | 6 Months Post-Randomization | 3.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Major Vascular Complications | 1 Year Post-Randomization | 3.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Major Vascular Complications | 1 Year Post-Randomization | 2.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Major Vascular Complications | Discharge/7 Days Post-Randomization | 1.5 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Major Vascular Complications | 6 Months Post-Randomization | 2.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Major Vascular Complications | 30 Days Post-Randomization | 1.6 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Major Vascular Complications | 1 Year Post-Randomization | 2.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Major Vascular Complications | 30 Days Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Major Vascular Complications | 6 Months Post-Randomization | 2.0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Major Vascular Complications | Discharge/7 Days Post-Randomization | 1.4 percentage of participants |
Other Pre-specified
Rate of Mitral Apparatus Damage: Periprocedural
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed through 72 hours post index procedure
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Mitral Apparatus Damage: Periprocedural | 0 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mitral Apparatus Damage: Periprocedural | 0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mitral Apparatus Damage: Periprocedural | 0 Percentage of participants |
Other Pre-specified
Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definition.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 days/6 Months/1 Year is defined as subjects who experience an event through 30 days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at Discharge/7 Days Post-Randomization | 0.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at Discharge/7 Days Post-Randomization | 0.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 30 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 30 Days Post-Randomization | 0.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 30 Days Post-Randomization | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 6 Months Post-Randomization | 2.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 6 Months Post-Randomization | 2.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 6 Months Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 1 Year Post-Randomization | 5.0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 1 Year Post-Randomization | 3.8 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 1 Year Post-Randomization | 1.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 1 Year Post-Randomization | 2.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 6 Months Post-Randomization | 1.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 6 Months Post-Randomization | 0.7 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 30 Days Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 1 Year Post-Randomization | 1.8 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 6 Months Post-Randomization | 0.5 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 30 Days Post-Randomization | 0.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 30 Days Post-Randomization | 0.4 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 1 Year Post-Randomization | 3.9 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 30 Days Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 30 Days Post-Randomization | 1.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 1 Year Post-Randomization | 4.8 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 30 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at 6 Months Post-Randomization | 2 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 6 Months Post-Randomization | 2 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at 1 Year Post-Randomization | 3.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: all-cause at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: cardiovascular at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 6 Months Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Mortality: All-cause, Cardiovascular, and Non-cardiovascular | Mortality: non-cardiovascular at 1 Year Post-Randomization | 1.4 percentage of participants |
Other Pre-specified
Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure)
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at Discharge/7 Days Post-Randomization | 0.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at Discharge/7 Days Post-Randomization | 0.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 30 Days Post-Randomization | 0.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 30 Days Post-Randomization | 0.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 30 Days Post-Randomization | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 6 Months Post-Randomization | 1.5 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 6 Months Post-Randomization | 0.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 6 Months Post-Randomization | 1.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 1 Year Post-Randomization | 2.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 1 Year Post-Randomization | 0.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 1 Year Post-Randomization | 1.9 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 1 Year Post-Randomization | 0.7 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 6 Months Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 6 Months Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 30 Days Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 1 Year Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 6 Months Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 30 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 30 Days Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 1 Year Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 30 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 30 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 1 Year Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 30 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at 6 Months Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 6 Months Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at 1 Year Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | MI at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Periprocedural MI at Discharge/7 Days Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 6 Months Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Myocardial Infarction (MI): Periprocedural (≤72 Hours Post Index Procedure) and Spontaneous (>72 Hours Post Index Procedure) | Spontaneous MI at 1 Year Post-Randomization | 0 percentage of participants |
Other Pre-specified
Rate of New Onset of Atrial Fibrillation or Atrial Flutter
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at Discharge/7 Days Post-Randomization | 1.9 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 30 Days Post-Randomization | 2.2 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 30 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 6 Months Post-Randomization | 2.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 6 Months Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 1 Year Post-Randomization | 2.4 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 1 Year Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 30 Days Post-Randomization | 2.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 1 Year Post-Randomization | 2.4 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 30 Days Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 6 Months Post-Randomization | 2.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 6 Months Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at Discharge/7 Days Post-Randomization | 2.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at Discharge/7 Days Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 1 Year Post-Randomization | 0.1 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 30 Days Post-Randomization | 3.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at Discharge/7 Days Post-Randomization | 2.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 30 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 1 Year Post-Randomization | 3.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 6 Months Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial fibrillation at 6 Months Post-Randomization | 3.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Onset of Atrial Fibrillation or Atrial Flutter | New onset of atrial flutter at 1 Year Post-Randomization | 0 percentage of participants |
Other Pre-specified
Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | Discharge/7 Days Post-Randomization | 5.3 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 30 Days Post-Randomization | 8.6 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 6 Months Post-Randomization | 10.7 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 1 Year Post-Randomization | 11.4 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 1 Year Post-Randomization | 12.2 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | Discharge/7 Days Post-Randomization | 6.3 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 6 Months Post-Randomization | 10.9 percentage of participants |
| Commercial Valve - Main Randomized | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 30 Days Post-Randomization | 9.5 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 1 Year Post-Randomization | 8.2 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 30 Days Post-Randomization | 4.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | 6 Months Post-Randomization | 7.4 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of New Permanent Pacemaker Implantation (PPI) Resulting From New or Worsened Conduction Disturbances | Discharge/7 Days Post-Randomization | 1.4 percentage of participants |
Other Pre-specified
Rate of Prosthetic Aortic Valve Endocarditis
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | Discharge/7 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | 6 Months Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | 1 Year Post-Randomization | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | 1 Year Post-Randomization | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | 6 Months Post-Randomization | 0.0 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | Discharge/7 Days Post-Randomization | 0.0 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Endocarditis | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Endocarditis | Discharge/7 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Endocarditis | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Endocarditis | 6 Months Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Endocarditis | 1 Year Post-Randomization | 0.0 Percentage of participants |
Other Pre-specified
Rate of Prosthetic Aortic Valve Thrombosis
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | Discharge/7 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | 6 Months Post -Randomization | 0.4 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | 1 Year Post-Randomization | 0.7 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | 1 Year Post-Randomization | 2.6 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | Discharge/7 Days Post-Randomization | 0.0 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | 6 Months Post -Randomization | 1.8 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Prosthetic Aortic Valve Thrombosis | 30 Days Post-Randomization | 0.1 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Thrombosis | 1 Year Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Thrombosis | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Thrombosis | 6 Months Post -Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Prosthetic Aortic Valve Thrombosis | Discharge/7 Days Post-Randomization | 0.0 Percentage of participants |
Other Pre-specified
Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy)
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | Discharge/7 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 30 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 6 Months Post-Randomization | 0.1 percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 1 Year Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 1 Year Post-Randomization | 0.4 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | Discharge/7 Days Post-Randomization | 0 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 6 Months Post-Randomization | 0.1 percentage of participants |
| Commercial Valve - Main Randomized | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 30 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 1 Year Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 30 Days Post-Randomization | 0 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | 6 Months Post-Randomization | 0.7 percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Repeat Procedure for Valve-related Dysfunction (Surgical or Interventional Therapy) | Discharge/7 Days Post-Randomization | 0 percentage of participants |
Other Pre-specified
Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment)
Device Performance outcome, as measured by site reported data based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed for the duration of their procedure, an expected average of 1 Day (peri- and post-procedure)
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment) | 98.6 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment) | 99.3 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Successful Vascular Access, Delivery and Deployment of the Study Valve, and Successful Retrieval of the Delivery System (Site Reported Assessment) | 100.0 Percentage of participants |
Other Pre-specified
Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | Discharge/7 Days Post- Randomization | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 30 Days Post-Randomization | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 6 Months Post-Randomization | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 1 Year Post-Randomization | 0.7 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 1 Year Post-Randomization | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | Discharge/7 Days Post- Randomization | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 6 Months Post-Randomization | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 30 Days Post-Randomization | 0.1 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 1 Year Post-Randomization | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | 6 Months Post-Randomization | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Transcatheter Aortic Valve (TAV)-In-TAV Deployment | Discharge/7 Days Post- Randomization | 0.0 Percentage of participants |
Other Pre-specified
Rate of Valve Embolization
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Embolization | Discharge/7 Days Post-Randomization (whichever comes first) | 0.9 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Embolization | 30 Days Post-Randomization | 1.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Embolization | 6 Months Post-Randomization | 1.0 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Embolization | 1 Year Post-Randomization | 1.0 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Embolization | 1 Year Post-Randomization | 0.7 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Embolization | Discharge/7 Days Post-Randomization (whichever comes first) | 0.7 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Embolization | 6 Months Post-Randomization | 0.7 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Embolization | 30 Days Post-Randomization | 0.7 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Embolization | 1 Year Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Embolization | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Embolization | 6 Months Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Embolization | Discharge/7 Days Post-Randomization (whichever comes first) | 0.0 Percentage of participants |
Other Pre-specified
Rate of Valve Migration
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 Days, 6 Months, and 1 Year. Data for 2-10 years will be posted once data is complete.
Population: Intention-To-Treat (ITT): This population includes all subjects who sign an ICF, are enrolled in the trial, and are randomized, whether or not an assigned study device is implanted. A subject treatment group is based on the randomization assignment.~Evaluable for clinical endpoints at 30 Days/6 Months/1 Year is defined as subjects who experience an event through 30 Days/6 Months/1 Year post-randomization or who were event-free with last follow-up at least 23/150/335 days post- randomization.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Migration | Discharge/7 Days Post-Randomization (whichever comes first) | 0.1 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Migration | 30 Days Post-Randomization | 0.1 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Migration | 6 Months Post-Randomization | 0.1 Percentage of participants |
| ACURATE neo2 Valve - Main Randomized | Rate of Valve Migration | 1 Year Post-Randomization | 0.1 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Migration | 1 Year Post-Randomization | 0.3 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Migration | Discharge/7 Days Post-Randomization (whichever comes first) | 0.3 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Migration | 6 Months Post-Randomization | 0.3 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Valve Migration | 30 Days Post-Randomization | 0.3 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Migration | 1 Year Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Migration | 30 Days Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Migration | 6 Months Post-Randomization | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Valve Migration | Discharge/7 Days Post-Randomization (whichever comes first) | 0.0 Percentage of participants |
Other Pre-specified
Rate of Ventricular Septal Perforation: Periprocedural
Safety outcome adjudicated by an independent Clinical Events Committee (CEC) based on VARC-2 endpoints and definitions.
Time frame: Participants will be followed through 72 hours post index procedure
Population: Intention-To-Treat (ITT): This population includes 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. A subject treatment group is based on the randomization assignment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACURATE neo2 Valve - Main Randomized | Rate of Ventricular Septal Perforation: Periprocedural | 0.3 Percentage of participants |
| Commercial Valve - Main Randomized | Rate of Ventricular Septal Perforation: Periprocedural | 0.0 Percentage of participants |
| ACURATE neo2 Valve - Single-arm Roll-in | Rate of Ventricular Septal Perforation: Periprocedural | 0.0 Percentage of participants |