Severe Aortic Stenosis
Conditions
Brief summary
The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.
Interventions
DEVICEMedtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Sponsors
Medtronic Cardiovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and \<15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation; * Heart Team unanimously agree on treatment proposal and eligibility for randomization\* based on their clinical judgement (including anatomy assessment, risk factors, etc.); * Subject has severe aortic stenosis presenting with; 1. Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index \< 0.6cm2/m2 AND 2. Mean gradient \> 40mmHg or Vmax \> 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization \[or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) \<55%\] or velocity ratio \< 0.25; * Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater; * Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits; * Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;
Exclusion criteria
* Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm) * Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve); * A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated; * Blood dyscrasias as defined: leukopenia (WBC \<1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy; * Ongoing sepsis, including active endocarditis; * Any condition considered a contraindication to extracorporeal assistance; * Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization\* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe); * Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization\*; * Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; * Recent (within 6 months of randomization\*) cerebrovascular accident (CVA) or transient ischemic attack (TIA); * Active gastrointestinal (GI) bleeding that would preclude anticoagulation; * Subject refuses a blood transfusion; * Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits); * Multivessel coronary artery disease with a Syntax score \>22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned); * Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions; * Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams; * Currently participating in an investigational drug or another device trial (excluding registries); * Evidence of an acute myocardial infarction ≤30 days before the index procedure; * Need for emergency surgery for any reason; * True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR); * Extensive mediastinal radiation; * Liver failure (Child-C); * Reduced ventricular function with left ventricular ejection fraction (LVEF) \<20% as measured by resting echocardiogram; * Uncontrolled atrial fibrillation (e.g. resting heart rate \> 120 bpm); * Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements; * End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min; * Pulmonary Hypertension (systolic pressure\> 80mmHg); * Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) \< 750cc; * Frailty assessments identify: 1. Subject is \< 80 years of age and three or more of the following apply 2. Subject is ≥ 80 years of age and two or more of the following apply * Wheelchair bound * Resides in an institutional care facility (e.g., nursing home, skilled care center) * Body Mass Index \< 20 kg/m2 * Grip Strength \< 16 kg * Katz Index Score ≤ 4 * Albumin \< 3.5 g/dL; * Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm) Note: Additional anatomical and vascular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability | 24 months | All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| Percentage of Participants With Individual MACCE Components | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| Percentage of Participants With Major Adverse Events (MAE) | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis. |
| Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | — |
| Change in NYHA Class From Baseline | Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (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. |
| Change in Distance Walked During 6-minute Walk Test (6MWT) | From baseline to 30 days, baseline to 12 months, and baseline to 24 months | Change in distance walked during 6MWT from baseline |
| Ratio of Days Alive Out of Hospital Versus Total Days Alive | 12 and 24 months | — |
| Quality of Life (QoL) Change From Baseline | Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete. | QoL summary score change from baseline using the following measures: * 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. * 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state. |
| Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete | Using the following measure: -Transvalvular mean gradient |
| Effective Orifice Area as an Assessment of Prosthetic Valve Performance | discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete | Using the following measure: -Effective Orifice Area (cm\^2) |
| Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete | Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) |
| Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | — |
| Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete | — |
| Percentage of Participants With Stroke and TIAs | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | Strokes (of any severity) and Transient Ischemic Attacks (TIAs) |
| Peri-procedural Neurological Injury | discharge or 7 days post index procedure (whichever occurred first) | Neurological injury (stroke, TIA, or encephalopathy) |
| Index Procedure Related Major Adverse Events (MAEs) | Procedure through 30 day visit | Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure. |
| Length of Index Procedure Hospital Stay | Number of days from admission to discharge (expected average of 7 days) | — |
| Presence of Atrial Fibrillation | post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete. | — |
| Device Success (Medtronic CoreValve® System Subjects Only) | Number of days from admission to discharge (expected average of 7 days) | * Absence of procedural mortality * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation) |
| Procedural Success (Medtronic CoreValve® System Subjects Only) | Number of days from admission to discharge (expected average of 7 days) | Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE) |
| Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) | 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete. | Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered PVD defined as: * Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA \<1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI \<0. 35 m/s) OR * moderate or severe total AR |
| Percentage of Participants With Early Safety Endpoint | 30 Days | Percentage of participants with VARC II early safety composite at 30 days |
| Percentage of Participants With Clinical Efficacy (After 30 Days) | 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete | Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction. |
| Percentage of Participants With Time-Related Safety | 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available. | The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI \<0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events. |
| Resheath and Recapture Success (Evolut R Only) | Procedure | The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter. |
Countries
Canada, Denmark, Germany, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORStephan Windecker, MD, PhD
Bern University Hospital
PRINCIPAL_INVESTIGATORRüdiger Lange, MD, PhD
Deutsches Herzzentrum München
PRINCIPAL_INVESTIGATORThomas Walther, MD, PhD
Kerckhoff Klinik
PRINCIPAL_INVESTIGATORMichael J. Reardon, MD
The Methodist Hospital Research Institute
PRINCIPAL_INVESTIGATORDavid H. Adams, MD
Icahn School of Medicine at Mount Sinai
STUDY_CHAIRNicolas M. Van Mieghem, MD
Erasmus Medical Center
STUDY_CHAIRPatrick W. Serruys, MD, PhD
National Heart & Lung Institute of Imperial College in London
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Medtronic CoreValve® System TAVI Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI) | 864 |
| SAVR Surgical Aortic Valve Replacement (SAVR) | 796 |
| Total | 1,660 |
Baseline characteristics
| Characteristic | SAVR | Total | Medtronic CoreValve® System TAVI |
|---|---|---|---|
| Age, Continuous | 79.7 years STANDARD_DEVIATION 6.1 | 79.8 years STANDARD_DEVIATION 6.2 | 79.9 years STANDARD_DEVIATION 6.2 |
| Body Surface Area | 1.9 meters squared STANDARD_DEVIATION 0.2 | 1.9 meters squared STANDARD_DEVIATION 0.2 | 1.9 meters squared STANDARD_DEVIATION 0.2 |
| Logistic EuroSCORE | 11.6 percentage of predicted mortality STANDARD_DEVIATION 8 | 11.8 percentage of predicted mortality STANDARD_DEVIATION 7.8 | 11.9 percentage of predicted mortality STANDARD_DEVIATION 7.6 |
| NYHA Class I | 0 Participants | 0 Participants | 0 Participants |
| NYHA Class II | 333 Participants | 677 Participants | 344 Participants |
| NYHA Class III | 411 Participants | 883 Participants | 472 Participants |
| NYHA Class IV | 52 Participants | 100 Participants | 48 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 13 Participants | 7 Participants |
| Race/Ethnicity, Customized Black/African American | 21 Participants | 39 Participants | 18 Participants |
| Race/Ethnicity, Customized Hispanic or Latino Ethnicity | 23 Participants | 41 Participants | 18 Participants |
| Sex: Female, Male Female | 358 Participants | 724 Participants | 366 Participants |
| Sex: Female, Male Male | 438 Participants | 936 Participants | 498 Participants |
| STS Score | 4.5 % risk of mortality STANDARD_DEVIATION 1.6 | 4.5 % risk of mortality STANDARD_DEVIATION 1.6 | 4.4 % risk of mortality STANDARD_DEVIATION 1.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 98 / 864 | 80 / 796 |
| other Total, other adverse events | 803 / 864 | 754 / 796 |
| serious Total, serious adverse events | 718 / 864 | 694 / 796 |
Outcome results
Primary
All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.
Time frame: 24 months
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Medtronic CoreValve® System TAVI | All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability | 12.6 Percentage of Participants |
| SAVR | All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability | 14.0 Percentage of Participants |
Comparison: Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.Bayesian
Secondary
Change in Distance Walked During 6-minute Walk Test (6MWT)
Change in distance walked during 6MWT from baseline
Time frame: From baseline to 30 days, baseline to 12 months, and baseline to 24 months
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic CoreValve® System TAVI | Change in Distance Walked During 6-minute Walk Test (6MWT) | 30 days | 35.4 meters | Standard Deviation 99.2 |
| Medtronic CoreValve® System TAVI | Change in Distance Walked During 6-minute Walk Test (6MWT) | 12 months | 37.1 meters | Standard Deviation 103.5 |
| Medtronic CoreValve® System TAVI | Change in Distance Walked During 6-minute Walk Test (6MWT) | 24 months | 26.5 meters | Standard Deviation 115.4 |
| SAVR | Change in Distance Walked During 6-minute Walk Test (6MWT) | 30 days | -14.4 meters | Standard Deviation 108.7 |
| SAVR | Change in Distance Walked During 6-minute Walk Test (6MWT) | 12 months | 17.8 meters | Standard Deviation 102 |
| SAVR | Change in Distance Walked During 6-minute Walk Test (6MWT) | 24 months | 11.7 meters | Standard Deviation 102.7 |
Secondary
Change in NYHA Class From Baseline
Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (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: Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic CoreValve® System TAVI | Change in NYHA Class From Baseline | 6 month | -1.3 units on a scale | Standard Deviation 0.8 |
| Medtronic CoreValve® System TAVI | Change in NYHA Class From Baseline | 18 month | -1.2 units on a scale | Standard Deviation 0.8 |
| Medtronic CoreValve® System TAVI | Change in NYHA Class From Baseline | 12 month | -1.3 units on a scale | Standard Deviation 0.8 |
| Medtronic CoreValve® System TAVI | Change in NYHA Class From Baseline | 24 month | -1.2 units on a scale | Standard Deviation 0.8 |
| Medtronic CoreValve® System TAVI | Change in NYHA Class From Baseline | 30 day | -1.2 units on a scale | Standard Deviation 0.8 |
| SAVR | Change in NYHA Class From Baseline | 24 month | -1.2 units on a scale | Standard Deviation 0.8 |
| SAVR | Change in NYHA Class From Baseline | 30 day | -1.0 units on a scale | Standard Deviation 0.9 |
| SAVR | Change in NYHA Class From Baseline | 6 month | -1.3 units on a scale | Standard Deviation 0.8 |
| SAVR | Change in NYHA Class From Baseline | 12 month | -1.3 units on a scale | Standard Deviation 0.8 |
| SAVR | Change in NYHA Class From Baseline | 18 month | -1.2 units on a scale | Standard Deviation 0.8 |
Secondary
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Time frame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Population: Participant Population= Consisted of all randomized subjects with a valve implanted
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- None | 24.9 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Trace | 35.7 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Mild | 35.9 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Moderate | 3.2 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Severe | 0.2 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- None | 28.4 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Trace | 32.2 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Mild | 34.7 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Moderate | 4.6 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Severe | 0.1 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- None | 32.0 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Trace | 28.8 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Mild | 34.1 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Moderate | 5.1 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Severe | 0.0 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- None | 35.1 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Trace | 30.5 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Mild | 30.0 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Moderate | 4.2 Percentage of participants |
| Medtronic CoreValve® System TAVI | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Severe | 0.2 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Mild | 6.2 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- None | 67.9 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- None | 67.6 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Trace | 24.6 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- None | 67.7 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Mild | 6.8 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Trace | 23.5 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Moderate | 0.7 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Severe | 0.2 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | Discharge : Total Aortic Regurgitation- Severe | 0.0 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Mild | 8.3 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- None | 67.0 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Trace | 25.3 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Trace | 24.3 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Moderate | 0.7 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Mild | 7.8 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 24 months : Total Aortic Regurgitation- Moderate | 0.6 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Moderate | 0.8 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 12 months : Total Aortic Regurgitation- Severe | 0.0 Percentage of participants |
| SAVR | Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance | 6 months : Total Aortic Regurgitation- Severe | 0.2 Percentage of participants |
Secondary
Device Success (Medtronic CoreValve® System Subjects Only)
* Absence of procedural mortality * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Time frame: Number of days from admission to discharge (expected average of 7 days)
Population: Participant Population =Consisted of all randomized subjects with a TAVR index procedure who were evaluable for device success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve® System TAVI | Device Success (Medtronic CoreValve® System Subjects Only) | 77.0 percentage of participants |
Secondary
Effective Orifice Area as an Assessment of Prosthetic Valve Performance
Using the following measure: -Effective Orifice Area (cm\^2)
Time frame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Population: Participant Population= Consisted of all randomized subjects with a valve implanted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic CoreValve® System TAVI | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | discharge EOA | 2.13 cm^2 | Standard Deviation 0.57 |
| Medtronic CoreValve® System TAVI | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | 6 months EOA | 2.14 cm^2 | Standard Deviation 0.61 |
| Medtronic CoreValve® System TAVI | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | 12 months EOA | 2.13 cm^2 | Standard Deviation 0.59 |
| Medtronic CoreValve® System TAVI | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | 24 months EOA | 2.15 cm^2 | Standard Deviation 0.63 |
| SAVR | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | 24 months EOA | 1.77 cm^2 | Standard Deviation 0.55 |
| SAVR | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | discharge EOA | 1.82 cm^2 | Standard Deviation 0.63 |
| SAVR | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | 12 months EOA | 1.78 cm^2 | Standard Deviation 0.59 |
| SAVR | Effective Orifice Area as an Assessment of Prosthetic Valve Performance | 6 months EOA | 1.80 cm^2 | Standard Deviation 0.57 |
Secondary
Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)
Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered PVD defined as: * Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA \<1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI \<0. 35 m/s) OR * moderate or severe total AR
Time frame: 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all subjects with a valve implanted
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) | 6 month | 6.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) | 12 month | 6.7 percentage of participants |
| Medtronic CoreValve® System TAVI | Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) | 24 month | 6.0 percentage of participants |
| SAVR | Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) | 6 month | 4.1 percentage of participants |
| SAVR | Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) | 12 month | 6.4 percentage of participants |
| SAVR | Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) | 24 month | 5.8 percentage of participants |
Secondary
Index Procedure Related Major Adverse Events (MAEs)
Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.
Time frame: Procedure through 30 day visit
Population: Participant Population= Consisted of all randomized subjects with an index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve® System TAVI | Index Procedure Related Major Adverse Events (MAEs) | 23.5 percentage of participants |
| SAVR | Index Procedure Related Major Adverse Events (MAEs) | 30.4 percentage of participants |
Secondary
Length of Index Procedure Hospital Stay
Time frame: Number of days from admission to discharge (expected average of 7 days)
Population: Participant Population= Consisted of all randomized subjects with an index procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Length of Index Procedure Hospital Stay | 5.7 days | Standard Deviation 4.9 |
| SAVR | Length of Index Procedure Hospital Stay | 9.8 days | Standard Deviation 8 |
Secondary
Percentage of Participants With Aortic Valve Disease Related Hospitalizations
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 6 months | 6.6 percentage of particpants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 18 months | 10.8 percentage of particpants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 12 months | 8.6 percentage of particpants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 24 months | 12.8 percentage of particpants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 30 days | 2.8 percentage of particpants |
| SAVR | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 24 months | 9.5 percentage of particpants |
| SAVR | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 30 days | 4.1 percentage of particpants |
| SAVR | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 6 months | 5.8 percentage of particpants |
| SAVR | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 12 months | 7.4 percentage of particpants |
| SAVR | Percentage of Participants With Aortic Valve Disease Related Hospitalizations | 18 months | 8.4 percentage of particpants |
Secondary
Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 30 day cardiovascular deaths | 2.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 30 day valve related deaths | 0.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 6 month cardiovascular deaths | 3.2 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 6 month valve related deaths | 0.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 12 month cardiovascular deaths | 4.7 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 12 month valve related deaths | 0.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 18 month cardiovascular deaths | 5.9 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 18 month valve related deaths | 0.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 24 month cardiovascular deaths | 7.8 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 24 month valve related deaths | 0.0 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 18 month valve related deaths | 0.1 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 30 day cardiovascular deaths | 1.6 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 12 month valve related deaths | 0.1 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 30 day valve related deaths | 0.0 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 24 month valve related deaths | 0.1 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 6 month cardiovascular deaths | 3.9 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 18 month cardiovascular deaths | 6.1 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 6 month valve related deaths | 0.1 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 24 month cardiovascular deaths | 7.1 percentage of participants |
| SAVR | Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths | 12 month cardiovascular deaths | 5.3 percentage of participants |
Secondary
Percentage of Participants With Clinical Efficacy (After 30 Days)
Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.
Time frame: 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Clinical Efficacy (After 30 Days) | 6 months | 12.8 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Clinical Efficacy (After 30 Days) | 12 months | 23.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Clinical Efficacy (After 30 Days) | 24 months | 33.9 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Clinical Efficacy (After 30 Days) | 18 months | 26.3 percentage of participants |
| SAVR | Percentage of Participants With Clinical Efficacy (After 30 Days) | 18 months | 22.6 percentage of participants |
| SAVR | Percentage of Participants With Clinical Efficacy (After 30 Days) | 6 months | 9.9 percentage of participants |
| SAVR | Percentage of Participants With Clinical Efficacy (After 30 Days) | 24 months | 33.0 percentage of participants |
| SAVR | Percentage of Participants With Clinical Efficacy (After 30 Days) | 12 months | 21.0 percentage of participants |
Secondary
Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
Time frame: 30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 months | 27.2 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 18 months | 30.1 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 12 months | 28.3 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 24 months | 30.9 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 days | 25.6 percentage of participants |
| SAVR | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 24 months | 9.8 percentage of participants |
| SAVR | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 days | 6.5 percentage of participants |
| SAVR | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 months | 7.6 percentage of participants |
| SAVR | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 12 months | 8.6 percentage of participants |
| SAVR | Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation | 18 months | 9.2 percentage of participants |
Secondary
Percentage of Participants With Early Safety Endpoint
Percentage of participants with VARC II early safety composite at 30 days
Time frame: 30 Days
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Early Safety Endpoint | 12.5 percentage of participants |
| SAVR | Percentage of Participants With Early Safety Endpoint | 15.8 percentage of participants |
Secondary
Percentage of Participants With Individual MACCE Components
MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 30 day All Cause Mortality | 2.1 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 30 day MI | 0.8 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 30 day Stroke | 3.3 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 30 day Reintervention | 0.8 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 6 month All Cause Mortality | 4.2 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 6 month MI | 1.2 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 6 month Stroke | 4.6 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 6 month Reintervention | 1.8 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 12 month All Cause Mortality | 6.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 12 month MI | 1.9 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 12 month Stroke | 5.2 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 12 month Reintervention | 2.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 18 month All Cause Mortality | 8.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 18 month MI | 2.2 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 18 month Stroke | 5.7 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 18 month Reintervention | 2.4 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 24 month All Cause Mortality | 11.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 24 month MI | 2.7 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 24 month Stroke | 6.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Individual MACCE Components | 24 month Reintervention | 2.4 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 24 month MI | 2.2 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 30 day All Cause Mortality | 1.6 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 12 month Stroke | 6.9 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 30 day MI | 0.9 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 18 month Reintervention | 0.5 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 30 day Stroke | 5.4 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 12 month Reintervention | 0.5 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 30 day Reintervention | 0.1 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 24 month Reintervention | 0.5 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 6 month All Cause Mortality | 4.7 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 18 month All Cause Mortality | 7.9 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 6 month MI | 1.4 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 24 month All Cause Mortality | 10.5 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 6 month Stroke | 6.6 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 18 month MI | 1.8 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 6 month Reintervention | 0.3 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 24 month Stroke | 8.5 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 12 month All Cause Mortality | 6.7 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 18 month Stroke | 7.5 percentage of participants |
| SAVR | Percentage of Participants With Individual MACCE Components | 12 month MI | 1.4 percentage of participants |
Secondary
Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
MACCE is defined as a composite of: * All-cause death * Myocardial infarction (MI) * All stroke, and * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 6 months | 9.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 18 months | 15.6 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 12 months | 13.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 24 months | 18.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 30 days | 5.7 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 24 months | 18.2 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 30 days | 7.3 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 6 months | 10.7 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 12 months | 13.0 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | 18 months | 14.8 percentage of participants |
Secondary
Percentage of Participants With Major Adverse Events (MAE)
Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Events (MAE) | 12 months | 33.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Events (MAE) | 6 months | 28.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Events (MAE) | 18 months | 36.6 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Events (MAE) | 24 months | 40.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Major Adverse Events (MAE) | 30 days | 23.7 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Events (MAE) | 24 months | 41.8 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Events (MAE) | 30 days | 30.3 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Events (MAE) | 18 months | 38.4 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Events (MAE) | 6 months | 33.6 percentage of participants |
| SAVR | Percentage of Participants With Major Adverse Events (MAE) | 12 months | 35.8 percentage of participants |
Secondary
Percentage of Participants With Stroke and TIAs
Strokes (of any severity) and Transient Ischemic Attacks (TIAs)
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Stroke and TIAs | 18 months | 8.8 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Stroke and TIAs | 30 days | 4.4 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Stroke and TIAs | 6 months | 6.9 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Stroke and TIAs | 12 months | 8.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Stroke and TIAs | 24 months | 9.5 percentage of participants |
| SAVR | Percentage of Participants With Stroke and TIAs | 24 months | 11.2 percentage of participants |
| SAVR | Percentage of Participants With Stroke and TIAs | 12 months | 8.6 percentage of participants |
| SAVR | Percentage of Participants With Stroke and TIAs | 30 days | 6.3 percentage of participants |
| SAVR | Percentage of Participants With Stroke and TIAs | 18 months | 9.4 percentage of participants |
| SAVR | Percentage of Participants With Stroke and TIAs | 6 months | 7.8 percentage of participants |
Secondary
Percentage of Participants With Time-Related Safety
The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI \<0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.
Time frame: 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Percentage of Participants With Time-Related Safety | 6 months | 38.5 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Time-Related Safety | 18 months | 42.1 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Time-Related Safety | 12 months | 45.1 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Time-Related Safety | 24 months | 53.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Percentage of Participants With Time-Related Safety | 30 days | 28.8 percentage of participants |
| SAVR | Percentage of Participants With Time-Related Safety | 24 months | 77.3 percentage of participants |
| SAVR | Percentage of Participants With Time-Related Safety | 30 days | 61.7 percentage of participants |
| SAVR | Percentage of Participants With Time-Related Safety | 6 months | 69.6 percentage of participants |
| SAVR | Percentage of Participants With Time-Related Safety | 12 months | 72.1 percentage of participants |
| SAVR | Percentage of Participants With Time-Related Safety | 18 months | 67.8 percentage of participants |
Secondary
Peri-procedural Neurological Injury
Neurological injury (stroke, TIA, or encephalopathy)
Time frame: discharge or 7 days post index procedure (whichever occurred first)
Population: Participant Population= Consisted of all randomized subjects with an index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve® System TAVI | Peri-procedural Neurological Injury | 4.8 percentage of participants |
| SAVR | Peri-procedural Neurological Injury | 12.3 percentage of participants |
Secondary
Presence of Atrial Fibrillation
Time frame: post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Presence of Atrial Fibrillation | post procedure | 12.8 percentage of participants |
| Medtronic CoreValve® System TAVI | Presence of Atrial Fibrillation | discharge | 14.0 percentage of participants |
| Medtronic CoreValve® System TAVI | Presence of Atrial Fibrillation | 30 days | 13.6 percentage of participants |
| Medtronic CoreValve® System TAVI | Presence of Atrial Fibrillation | 6 months | 14.1 percentage of participants |
| Medtronic CoreValve® System TAVI | Presence of Atrial Fibrillation | 12 months | 13.4 percentage of participants |
| Medtronic CoreValve® System TAVI | Presence of Atrial Fibrillation | 18 months | 13.6 percentage of participants |
| Medtronic CoreValve® System TAVI | Presence of Atrial Fibrillation | 24 months | 15.1 percentage of participants |
| SAVR | Presence of Atrial Fibrillation | 6 months | 12.1 percentage of participants |
| SAVR | Presence of Atrial Fibrillation | post procedure | 8.7 percentage of participants |
| SAVR | Presence of Atrial Fibrillation | 24 months | 12.2 percentage of participants |
| SAVR | Presence of Atrial Fibrillation | discharge | 22.2 percentage of participants |
| SAVR | Presence of Atrial Fibrillation | 12 months | 11.7 percentage of participants |
| SAVR | Presence of Atrial Fibrillation | 30 days | 14.4 percentage of participants |
| SAVR | Presence of Atrial Fibrillation | 18 months | 11.9 percentage of participants |
Secondary
Procedural Success (Medtronic CoreValve® System Subjects Only)
Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: Number of days from admission to discharge (expected average of 7 days)
Population: Participant Population= Consisted of all randomized subjects with a TAVR index procedure who were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medtronic CoreValve® System TAVI | Procedural Success (Medtronic CoreValve® System Subjects Only) | 74.7 percentage of participants |
Secondary
Quality of Life (QoL) Change From Baseline
QoL summary score change from baseline using the following measures: * 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. * 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Time frame: Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 12 month KCCQ- Clinical | 15.1 units on a scale | Standard Deviation 21.4 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 30 day EQ-5D | 0.06 units on a scale | Standard Deviation 0.18 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 12 month SF-36-Physical | 5.2 units on a scale | Standard Deviation 9.9 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 6 month KCCQ- Overall | 21.9 units on a scale | Standard Deviation 22.3 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 12 month SF-36-Mental | 4.0 units on a scale | Standard Deviation 11.3 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 30 day KCCQ- Clinical | 14.9 units on a scale | Standard Deviation 21.2 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 12 month EQ-5D | 0.04 units on a scale | Standard Deviation 0.16 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 6 month KCCQ- Clinical | 16.5 units on a scale | Standard Deviation 21.5 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 18 month KCCQ- Overall | 19.7 units on a scale | Standard Deviation 21.5 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 3 month SF-36-Physical | 7.4 units on a scale | Standard Deviation 10.5 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 18 month KCCQ- Clinical | 14.0 units on a scale | Standard Deviation 20.7 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 6 month SF-36-Physical | 6.3 units on a scale | Standard Deviation 10.3 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 18 month SF-36-Physical | 4.2 units on a scale | Standard Deviation 10.4 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 30 day SF-36-Mental | 2.6 units on a scale | Standard Deviation 12.3 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 18 month SF-36-Mental | 4.3 units on a scale | Standard Deviation 11.1 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 6 month SF-36-Mental | 3.9 units on a scale | Standard Deviation 11.4 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 18 month EQ-5D | 0.03 units on a scale | Standard Deviation 0.17 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 3 month SF-36-Mental | 4.6 units on a scale | Standard Deviation 11.7 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 24 month KCCQ- Overall | 18.9 units on a scale | Standard Deviation 21.2 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 6 month EQ-5D | 0.04 units on a scale | Standard Deviation 0.18 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 24 month KCCQ- Clinical | 12.7 units on a scale | Standard Deviation 20.5 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 30 day SF-36-Physical | 5.7 units on a scale | Standard Deviation 10.4 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 24 month SF-36-Physical | 3.9 units on a scale | Standard Deviation 9.9 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 12 month KCCQ- Overall | 20.6 units on a scale | Standard Deviation 22.3 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 24 month SF-36-Mental | 3.6 units on a scale | Standard Deviation 11.3 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 3 month EQ-5D | 0.06 units on a scale | Standard Deviation 0.18 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 24 month EQ-5D | 0.02 units on a scale | Standard Deviation 0.17 |
| Medtronic CoreValve® System TAVI | Quality of Life (QoL) Change From Baseline | 30 day KCCQ- Overall | 18.4 units on a scale | Standard Deviation 22.8 |
| SAVR | Quality of Life (QoL) Change From Baseline | 24 month EQ-5D | 0.02 units on a scale | Standard Deviation 0.19 |
| SAVR | Quality of Life (QoL) Change From Baseline | 30 day KCCQ- Overall | 5.9 units on a scale | Standard Deviation 27 |
| SAVR | Quality of Life (QoL) Change From Baseline | 30 day KCCQ- Clinical | 4.0 units on a scale | Standard Deviation 26 |
| SAVR | Quality of Life (QoL) Change From Baseline | 30 day SF-36-Physical | -1.1 units on a scale | Standard Deviation 11 |
| SAVR | Quality of Life (QoL) Change From Baseline | 30 day SF-36-Mental | -0.6 units on a scale | Standard Deviation 13.7 |
| SAVR | Quality of Life (QoL) Change From Baseline | 30 day EQ-5D | -0.02 units on a scale | Standard Deviation 0.21 |
| SAVR | Quality of Life (QoL) Change From Baseline | 3 month SF-36-Physical | 5.6 units on a scale | Standard Deviation 10.5 |
| SAVR | Quality of Life (QoL) Change From Baseline | 3 month SF-36-Mental | 4.6 units on a scale | Standard Deviation 12.6 |
| SAVR | Quality of Life (QoL) Change From Baseline | 3 month EQ-5D | 0.05 units on a scale | Standard Deviation 0.18 |
| SAVR | Quality of Life (QoL) Change From Baseline | 6 month KCCQ- Overall | 21.3 units on a scale | Standard Deviation 22.3 |
| SAVR | Quality of Life (QoL) Change From Baseline | 6 month KCCQ- Clinical | 15.9 units on a scale | Standard Deviation 21.7 |
| SAVR | Quality of Life (QoL) Change From Baseline | 6 month SF-36-Physical | 6.3 units on a scale | Standard Deviation 10.5 |
| SAVR | Quality of Life (QoL) Change From Baseline | 6 month SF-36-Mental | 3.6 units on a scale | Standard Deviation 11.9 |
| SAVR | Quality of Life (QoL) Change From Baseline | 6 month EQ-5D | 0.05 units on a scale | Standard Deviation 0.17 |
| SAVR | Quality of Life (QoL) Change From Baseline | 12 month KCCQ- Overall | 20.5 units on a scale | Standard Deviation 22.2 |
| SAVR | Quality of Life (QoL) Change From Baseline | 12 month KCCQ- Clinical | 14.8 units on a scale | Standard Deviation 21.6 |
| SAVR | Quality of Life (QoL) Change From Baseline | 12 month SF-36-Physical | 5.2 units on a scale | Standard Deviation 10.2 |
| SAVR | Quality of Life (QoL) Change From Baseline | 12 month SF-36-Mental | 4.1 units on a scale | Standard Deviation 12 |
| SAVR | Quality of Life (QoL) Change From Baseline | 12 month EQ-5D | 0.03 units on a scale | Standard Deviation 0.18 |
| SAVR | Quality of Life (QoL) Change From Baseline | 18 month KCCQ- Overall | 20.2 units on a scale | Standard Deviation 22.1 |
| SAVR | Quality of Life (QoL) Change From Baseline | 18 month KCCQ- Clinical | 14.0 units on a scale | Standard Deviation 21.9 |
| SAVR | Quality of Life (QoL) Change From Baseline | 18 month SF-36-Physical | 4.3 units on a scale | Standard Deviation 10.8 |
| SAVR | Quality of Life (QoL) Change From Baseline | 18 month SF-36-Mental | 3.8 units on a scale | Standard Deviation 11.9 |
| SAVR | Quality of Life (QoL) Change From Baseline | 18 month EQ-5D | 0.03 units on a scale | Standard Deviation 0.17 |
| SAVR | Quality of Life (QoL) Change From Baseline | 24 month KCCQ- Overall | 18.6 units on a scale | Standard Deviation 22.9 |
| SAVR | Quality of Life (QoL) Change From Baseline | 24 month KCCQ- Clinical | 12.3 units on a scale | Standard Deviation 22.5 |
| SAVR | Quality of Life (QoL) Change From Baseline | 24 month SF-36-Physical | 4.0 units on a scale | Standard Deviation 10.8 |
| SAVR | Quality of Life (QoL) Change From Baseline | 24 month SF-36-Mental | 3.7 units on a scale | Standard Deviation 12.2 |
Secondary
Ratio of Days Alive Out of Hospital Versus Total Days Alive
Time frame: 12 and 24 months
Population: Participant Population= Consisted of all randomized subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic CoreValve® System TAVI | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 12 months | 0.96 ratio | Standard Deviation 0.12 |
| Medtronic CoreValve® System TAVI | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 24 months | 0.96 ratio | Standard Deviation 0.12 |
| SAVR | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 12 months | 0.93 ratio | Standard Deviation 0.15 |
| SAVR | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 24 months | 0.95 ratio | Standard Deviation 0.15 |
Secondary
Resheath and Recapture Success (Evolut R Only)
The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.
Time frame: Procedure
Population: Participant Population= Consisted of all subjects in whom the resheath or recapture feature of the Evolut R system was attempted
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Medtronic CoreValve® System TAVI | Resheath and Recapture Success (Evolut R Only) | Resheath | 100 percentage of attempts |
| Medtronic CoreValve® System TAVI | Resheath and Recapture Success (Evolut R Only) | Recapture | 89.7 percentage of attempts |
| Medtronic CoreValve® System TAVI | Resheath and Recapture Success (Evolut R Only) | Resheath or Recapture | 92.5 percentage of attempts |
Secondary
Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance
Using the following measure: -Transvalvular mean gradient
Time frame: discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete
Population: Participant Population= Consisted of all randomized subjects with a valve implanted
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Medtronic CoreValve® System TAVI | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | discharge | 8.82 mmHg | Standard Deviation 3.89 |
| Medtronic CoreValve® System TAVI | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | 6 months | 8.28 mmHg | Standard Deviation 3.88 |
| Medtronic CoreValve® System TAVI | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | 12 months | 8.34 mmHg | Standard Deviation 3.89 |
| Medtronic CoreValve® System TAVI | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | 24 months | 8.20 mmHg | Standard Deviation 3.85 |
| SAVR | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | 24 months | 11.55 mmHg | Standard Deviation 5.43 |
| SAVR | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | discharge | 12.39 mmHg | Standard Deviation 5.71 |
| SAVR | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | 12 months | 11.57 mmHg | Standard Deviation 5.16 |
| SAVR | Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance | 6 months | 11.10 mmHg | Standard Deviation 4.72 |