Severe Aortic Stenosis
Conditions
Keywords
Valvular Heart Disease, Critical Aortic Stenosis, Severe Aortic Stenosis, Extreme Risk, High Risk, Aortic Valve Replacement
Brief summary
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted very high risk and high risk for aortic valve surgery.
Interventions
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. High Risk: Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of \< 50%) at 30 days. OR Extreme Risk: Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days. 2. Subject has senile degenerative aortic valve stenosis with: * Mean gradient \> 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND * An initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization 3. Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater. 4. The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site. 5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion criteria
Clinical 1. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment. 2. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure including bare metal and drug eluting stents. 3. Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy. 4. Untreated clinically significant coronary artery disease requiring revascularization. 5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 6. Need for emergency surgery for any reason. 7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram. 8. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 9. End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min. 10. Active GI bleeding that would preclude anticoagulation. 11. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: * Aspirin * Heparin (HIT/HITTS) and bivalirudin * Nitinol (titanium or nickel) * Ticlopidine and clopidogrel * Contrast media 12. Ongoing sepsis, including active endocarditis. 13. Subject refuses a blood transfusion. 14. Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions. 15. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. 16. 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). 17. Currently participating in an investigational drug or another device trial. 18. Symptomatic carotid or vertebral artery disease. Anatomical 19. High Risk:Native aortic annulus size \< 20 mm or \> 29 mm per the baseline diagnostic imaging (until 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort) OR Extreme Risk: Native aortic annulus size \< 18 mm or \> 29 mm per the baseline diagnostic imaging. (High risk and extreme risk upon 23mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort) 20. Pre-existing prosthetic heart valve any position. 21. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)). 22. Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation. 23. Moderate to severe mitral stenosis. 24. Hypertrophic obstructive cardiomyopathy. 25. Echocardiographic evidence of new or untreated intracardiac mass, thrombus or vegetation. 26. Severe basal septal hypertrophy with an outflow gradient. 27. Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \> 70° (for femoral and left subclavian/axillary access) and \> 30° (for right subclavian/axillary access). 28. Ascending aorta diameter \>43 mm if the aortic annulus diameter is 23-29 mm; ascending aortic diameter \> 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter \> 34 mm if the aortic annulus diameter is 18-20 mm (Extreme Risk only until 23 mm valve enrollment completion/closure in the CoreValve® US Pivotal Trial-High Risk Cohort). 29. Congenital bicuspid or unicuspid valve verified by echocardiography. 30. Sinus of valsalva anatomy that would prevent adequate coronary perfusion. Vascular 31. Transarterial access not able to accommodate an 18Fr sheath.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 1 year | All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Occurrence of Individual MACCE Components | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | Individual MACCE Components Include: * All Cause Mortality * MI * All stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| Major Adverse Events (MAEs) | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | MAEs Include: * MACCE * Acute Kidney Injury * Cardiac Tamponade * Prosthetic Valve Dysfunction * Cardiogenic Shock * Valve Endocarditis * Life-Threatening, Disabling or Major Bleeding * Major Vascular Complication * Cardiac Perforation * Device Migration/Valve Embolism |
| Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | — |
| Change From Baseline in NYHA Class | Baseline to 30 days, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete. | Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. 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 From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) | Baseline to 30 days, baseline to 1 year | Change in distance walked during 6MWT from baseline |
| Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive | 1 year | — |
| Quality of Life (QoL) Change | 30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set 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. * 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. * 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. |
| Echocardiographic Assessment of Valve Performance | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | Using the following measure: • Effective Orifice Area (EOA) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement. |
| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | MACCE is defined as a composite of: * All-Cause Death * Myocardial Infarction (MI) * All Stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| Cardiovascular Deaths and Valve-Related Deaths | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | — |
| Strokes and Transient Ischemic Attacks (TIAs) | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | Strokes (of any severity) and TIAs |
| Index Procedure Related MAEs | Procedure | — |
| Length of Index Procedure Hospital Stay | Number of days from admission to discharge | — |
| Device Success | Number of days from admission to discharge | Defined as: * Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system, * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function), * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted in the proper anatomical location |
| Procedural Success | Number of days from admission to discharge | Defined as device success and absence of in-hospital MACCE. |
| Prosthetic Valve Dysfunction (PVD) | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | PVD was defined according to VARC using the site reported echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met: * Peak velocity \>4 m/s * Mean gradient \>35 mmHg * EOA \< 0.8 cm2 * TVIV1 / TVIV2 \< 0.25 |
| Aortic Valve Hospitalizations | 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete. | — |
Countries
United States
Participant flow
Recruitment details
Between February 21, 2012 and April 15, 2014, 1658 subjects were enrolled in the Continued Access Extreme Risk Study at 45 centers in the US. Between October 19, 2012 and August 12, 2014, 1119 subjects were enrolled in the High Risk Study at the same 45 US centers.
Participants by arm
| Arm | Count |
|---|---|
| Extreme Risk: Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) | 1,257 |
| Extreme Risk: Non-Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) | 367 |
| High Risk High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) | 1,108 |
| Total | 2,732 |
Baseline characteristics
| Characteristic | Extreme Risk: Iliofemoral | Extreme Risk: Non-Iliofemoral | High Risk | Total |
|---|---|---|---|---|
| Age, Continuous | 83.5 years STANDARD_DEVIATION 8.1 | 81.9 years STANDARD_DEVIATION 8.2 | 83.6 years STANDARD_DEVIATION 7.1 | 83.3 years STANDARD_DEVIATION 7.7 |
| Body Surface Area | 1.9 m^2 STANDARD_DEVIATION 0.3 | 1.8 m^2 STANDARD_DEVIATION 0.3 | 1.9 m^2 STANDARD_DEVIATION 0.2 | 1.9 m^2 STANDARD_DEVIATION 0.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 4 Participants | 38 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1206 Participants | 360 Participants | 1056 Participants | 2622 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 3 Participants | 14 Participants | 31 Participants |
| Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) | 24.2 Percent of predicted mortality STANDARD_DEVIATION 17.1 | 24.2 Percent of predicted mortality STANDARD_DEVIATION 17.1 | 20.3 Percent of predicted mortality STANDARD_DEVIATION 13.5 | 22.6 Percent of predicted mortality STANDARD_DEVIATION 15.9 |
| New York Heart Association (NYHA) Classification NYHA Classification I | 0 participants | 0 participants | 0 participants | 0 participants |
| New York Heart Association (NYHA) Classification NYHA Classification II | 159 participants | 45 participants | 180 participants | 384 participants |
| New York Heart Association (NYHA) Classification NYHA Classification III | 881 participants | 248 participants | 811 participants | 1940 participants |
| New York Heart Association (NYHA) Classification NYHA Classification IV | 217 participants | 74 participants | 117 participants | 408 participants |
| Sex: Female, Male Female | 568 Participants | 185 Participants | 456 Participants | 1209 Participants |
| Sex: Female, Male Male | 689 Participants | 182 Participants | 652 Participants | 1523 Participants |
| Society of Thoracic Surgeons (STS) Risk Score | 9.1 Percent of predicted mortality STANDARD_DEVIATION 5.1 | 10.2 Percent of predicted mortality STANDARD_DEVIATION 5.6 | 7.7 Percent of predicted mortality STANDARD_DEVIATION 3.3 | 8.7 Percent of predicted mortality STANDARD_DEVIATION 4.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1,097 / 1,257 | 327 / 367 | 1,001 / 1,108 |
| serious Total, serious adverse events | 1,117 / 1,257 | 359 / 367 | 1,004 / 1,108 |
Outcome results
Primary
Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality
All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)
Time frame: 1 year
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: Iliofemoral | Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 22.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 30.8 percentage of participants, Kaplan-Meier |
| High Risk | Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 17.8 percentage of participants, Kaplan-Meier |
Secondary
Aortic Valve Hospitalizations
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Aortic Valve Hospitalizations | 6 month | 12.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Aortic Valve Hospitalizations | 30 day | 6.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Aortic Valve Hospitalizations | 1 year | 17.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Aortic Valve Hospitalizations | 6 month | 12.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Aortic Valve Hospitalizations | 30 day | 5.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Aortic Valve Hospitalizations | 1 year | 16.5 percentage of participants, Kaplan-Meier |
| High Risk | Aortic Valve Hospitalizations | 30 day | 5.6 percentage of participants, Kaplan-Meier |
| High Risk | Aortic Valve Hospitalizations | 1 year | 15.4 percentage of participants, Kaplan-Meier |
| High Risk | Aortic Valve Hospitalizations | 6 month | 11.8 percentage of participants, Kaplan-Meier |
Secondary
Cardiovascular Deaths and Valve-Related Deaths
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 30 day Cardiovascular Deaths | 4.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 30 day Valve Related Deaths | 1.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 6 month Cardiovascular Deaths | 11.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 6 month Valve Related Deaths | 3.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 1 year Cardiovascular Deaths | 16.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 1 year Valve Related Deaths | 5.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 1 year Valve Related Deaths | 6.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 30 day Cardiovascular Deaths | 9.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 6 month Valve Related Deaths | 5.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 1 year Cardiovascular Deaths | 22.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 30 day Valve Related Deaths | 4.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Cardiovascular Deaths and Valve-Related Deaths | 6 month Cardiovascular Deaths | 16.3 percentage of participants, Kaplan-Meier |
| High Risk | Cardiovascular Deaths and Valve-Related Deaths | 30 day Valve Related Deaths | 2.4 percentage of participants, Kaplan-Meier |
| High Risk | Cardiovascular Deaths and Valve-Related Deaths | 6 month Cardiovascular Deaths | 9.4 percentage of participants, Kaplan-Meier |
| High Risk | Cardiovascular Deaths and Valve-Related Deaths | 1 year Valve Related Deaths | 4.2 percentage of participants, Kaplan-Meier |
| High Risk | Cardiovascular Deaths and Valve-Related Deaths | 6 month Valve Related Deaths | 3.8 percentage of participants, Kaplan-Meier |
| High Risk | Cardiovascular Deaths and Valve-Related Deaths | 30 day Cardiovascular Deaths | 4.6 percentage of participants, Kaplan-Meier |
| High Risk | Cardiovascular Deaths and Valve-Related Deaths | 1 year Cardiovascular Deaths | 13.0 percentage of participants, Kaplan-Meier |
Secondary
Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT)
Change in distance walked during 6MWT from baseline
Time frame: Baseline to 30 days, baseline to 1 year
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: Iliofemoral | Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) | Baseline to 30 day | 46.3 meters | Standard Deviation 116.4 |
| Extreme Risk: Iliofemoral | Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) | Baseline to 1 year | 58.8 meters | Standard Deviation 121.2 |
| Extreme Risk: Non-Iliofemoral | Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) | Baseline to 30 day | 4.0 meters | Standard Deviation 110.4 |
| Extreme Risk: Non-Iliofemoral | Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) | Baseline to 1 year | 28.5 meters | Standard Deviation 137.4 |
| High Risk | Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) | Baseline to 30 day | 38.1 meters | Standard Deviation 100 |
| High Risk | Change From Baseline in Distance Walked During 6-Minute Walk Test (6MWT) | Baseline to 1 year | 55.5 meters | Standard Deviation 117.9 |
Secondary
Change From Baseline in NYHA Class
Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. 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, baseline to 6 months, baseline to 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: Iliofemoral | Change From Baseline in NYHA Class | Baseline to 6 month | -1.4 average classification level change | Standard Deviation 0.8 |
| Extreme Risk: Iliofemoral | Change From Baseline in NYHA Class | Baseline to 30 days | -1.2 average classification level change | Standard Deviation 0.8 |
| Extreme Risk: Iliofemoral | Change From Baseline in NYHA Class | Baseline to 1 year | -1.4 average classification level change | Standard Deviation 0.8 |
| Extreme Risk: Non-Iliofemoral | Change From Baseline in NYHA Class | Baseline to 6 month | -1.4 average classification level change | Standard Deviation 0.8 |
| Extreme Risk: Non-Iliofemoral | Change From Baseline in NYHA Class | Baseline to 30 days | -1.1 average classification level change | Standard Deviation 0.9 |
| Extreme Risk: Non-Iliofemoral | Change From Baseline in NYHA Class | Baseline to 1 year | -1.4 average classification level change | Standard Deviation 0.9 |
| High Risk | Change From Baseline in NYHA Class | Baseline to 30 days | -1.2 average classification level change | Standard Deviation 0.8 |
| High Risk | Change From Baseline in NYHA Class | Baseline to 1 year | -1.4 average classification level change | Standard Deviation 0.8 |
| High Risk | Change From Baseline in NYHA Class | Baseline to 6 month | -1.4 average classification level change | Standard Deviation 0.8 |
Secondary
Conduction Disturbance Requiring Permanent Pacemaker Implantation
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 month | 29.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day | 27.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 1 year | 31.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 month | 24.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 1 year | 25.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day | 23.0 percentage of participants, Kaplan-Meier |
| High Risk | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day | 28.8 percentage of participants, Kaplan-Meier |
| High Risk | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 1 year | 32.1 percentage of participants, Kaplan-Meier |
| High Risk | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 month | 30.5 percentage of participants, Kaplan-Meier |
Secondary
Device Success
Defined as: * Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system, * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function), * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted in the proper anatomical location
Time frame: Number of days from admission to discharge
Population: Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: Iliofemoral | Device Success | 84.9 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Device Success | 88.1 percentage of participants |
| High Risk | Device Success | 87.9 percentage of participants |
Secondary
Echocardiographic Assessment of Valve Performance
Using the following measure: • Transvalvular Mean Gradient analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population= Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day | 8.20 mmHg | Standard Deviation 4.26 |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month | 7.98 mmHg | Standard Deviation 3.63 |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year | 7.72 mmHg | Standard Deviation 3.4 |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day | 8.02 mmHg | Standard Deviation 3.53 |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month | 7.97 mmHg | Standard Deviation 3.48 |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year | 8.12 mmHg | Standard Deviation 3.93 |
Secondary
Echocardiographic Assessment of Valve Performance
Using the following measure: • Effective Orifice Area (EOA) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day | 1.77 cm^2 | Standard Deviation 0.53 |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month | 1.75 cm^2 | Standard Deviation 0.54 |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year | 1.78 cm^2 | Standard Deviation 0.54 |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day | 1.77 cm^2 | Standard Deviation 0.51 |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month | 1.78 cm^2 | Standard Deviation 0.49 |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year | 1.77 cm^2 | Standard Deviation 0.51 |
Secondary
Echocardiographic Assessment of Valve Performance
Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular) analyzed overall per Extreme Risk or High Risk. Iliofemoral access and non-iliofemoral access are not reported separate because this is a valve performance measurement.
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Severe | 0.2 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- None | 35.1 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Mild | 66.3 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Moderate | 6.1 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Mild | 58.5 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Severe | 0.2 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Moderate | 6.9 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- None | 39.8 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- None | 26.5 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Mild | 54.9 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Severe | 0.3 percentage of participants |
| Extreme Risk: Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Moderate | 5.1 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Severe | 0.3 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Moderate | 3.8 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Severe | 0.3 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- None | 28.7 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Mild | 65.2 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Moderate | 5.8 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- None | 37.8 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Mild | 58.1 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Moderate | 4.0 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Severe | 0.1 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- None | 39.9 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Mild | 56.0 percentage of participants |
Secondary
Index Procedure Related MAEs
Time frame: Procedure
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: Iliofemoral | Index Procedure Related MAEs | 46.4 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Index Procedure Related MAEs | 66.6 percentage of participants |
| High Risk | Index Procedure Related MAEs | 48.1 percentage of participants |
Secondary
Length of Index Procedure Hospital Stay
Time frame: Number of days from admission to discharge
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Length of Index Procedure Hospital Stay | 7.6 days | Standard Deviation 6.9 |
| Extreme Risk: Non-Iliofemoral | Length of Index Procedure Hospital Stay | 10.7 days | Standard Deviation 8.7 |
| High Risk | Length of Index Procedure Hospital Stay | 7.6 days | Standard Deviation 5.9 |
Secondary
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
MACCE is defined as a composite of: * All-Cause Death * Myocardial Infarction (MI) * All Stroke * 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 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day | 9.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 6 month | 19.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 1 year | 26.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 6 month | 28.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day | 16.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 1 year | 36.2 percentage of participants, Kaplan-Meier |
| High Risk | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 6 month | 17.2 percentage of participants, Kaplan-Meier |
| High Risk | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 1 year | 24.3 percentage of participants, Kaplan-Meier |
| High Risk | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day | 8.9 percentage of participants, Kaplan-Meier |
Secondary
Major Adverse Events (MAEs)
MAEs Include: * MACCE * Acute Kidney Injury * Cardiac Tamponade * Prosthetic Valve Dysfunction * Cardiogenic Shock * Valve Endocarditis * Life-Threatening, Disabling or Major Bleeding * Major Vascular Complication * Cardiac Perforation * Device Migration/Valve Embolism
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Major Adverse Events (MAEs) | 6 month | 53.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Major Adverse Events (MAEs) | 30 day | 46.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Major Adverse Events (MAEs) | 1 year | 57.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Major Adverse Events (MAEs) | 6 month | 73.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Major Adverse Events (MAEs) | 30 day | 67.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Major Adverse Events (MAEs) | 1 year | 76.4 percentage of participants, Kaplan-Meier |
| High Risk | Major Adverse Events (MAEs) | 30 day | 48.1 percentage of participants, Kaplan-Meier |
| High Risk | Major Adverse Events (MAEs) | 1 year | 59.3 percentage of participants, Kaplan-Meier |
| High Risk | Major Adverse Events (MAEs) | 6 month | 54.5 percentage of participants, Kaplan-Meier |
Secondary
Procedural Success
Defined as device success and absence of in-hospital MACCE.
Time frame: Number of days from admission to discharge
Population: Participant Population = Consisted of all subjects with an index procedure who were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: Iliofemoral | Procedural Success | 79.7 percentage of participants |
| Extreme Risk: Non-Iliofemoral | Procedural Success | 76.8 percentage of participants |
| High Risk | Procedural Success | 82.3 percentage of participants |
Secondary
Prosthetic Valve Dysfunction (PVD)
PVD was defined according to VARC using the site reported echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met: * Peak velocity \>4 m/s * Mean gradient \>35 mmHg * EOA \< 0.8 cm2 * TVIV1 / TVIV2 \< 0.25
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Stenosis | 1.0 Percentage of participants |
| Extreme Risk: Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Regurgitation | 3.0 Percentage of participants |
| Extreme Risk: Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Stenosis | 2.2 Percentage of participants |
| Extreme Risk: Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Regurgitation | 5.0 Percentage of participants |
| Extreme Risk: Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Stenosis | 2.8 Percentage of participants |
| Extreme Risk: Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Regurgitation | 5.8 Percentage of participants |
| Extreme Risk: Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Regurgitation | 3.8 Percentage of participants |
| Extreme Risk: Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Stenosis | 0.8 Percentage of participants |
| Extreme Risk: Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Regurgitation | 3.3 Percentage of participants |
| Extreme Risk: Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Stenosis | 1.6 Percentage of participants |
| Extreme Risk: Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Regurgitation | 1.9 Percentage of participants |
| Extreme Risk: Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Stenosis | 0.8 Percentage of participants |
| High Risk | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Regurgitation | 2.0 Percentage of participants |
| High Risk | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Stenosis | 2.0 Percentage of participants |
| High Risk | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Regurgitation | 4.5 Percentage of participants |
| High Risk | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Regurgitation | 3.1 Percentage of participants |
| High Risk | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Stenosis | 0.9 Percentage of participants |
| High Risk | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Stenosis | 2.5 Percentage of participants |
Secondary
Quality of Life (QoL) Change
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. * 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. * 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: 30 day, 6 month, 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ- Clinical | 23.8 units on a scale | Standard Deviation 27.9 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Overall | 26.3 units on a scale | Standard Deviation 26.4 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Physical | 7.1 units on a scale | Standard Deviation 10.7 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Mental | 6.0 units on a scale | Standard Deviation 13.9 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 30 day EQ-5D | 0.10 units on a scale | Standard Deviation 0.26 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ- Overall | 31.7 units on a scale | Standard Deviation 27.3 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ- Clinical | 25.8 units on a scale | Standard Deviation 27.7 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Physical | 7.6 units on a scale | Standard Deviation 11.1 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Mental | 6.9 units on a scale | Standard Deviation 13.9 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 6 month EQ-5D | 0.10 units on a scale | Standard Deviation 0.25 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ- Overall | 30.0 units on a scale | Standard Deviation 27.5 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Clinical | 21.7 units on a scale | Standard Deviation 26.6 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Physical | 6.6 units on a scale | Standard Deviation 11.7 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Mental | 6.6 units on a scale | Standard Deviation 13.9 |
| Extreme Risk: Iliofemoral | Quality of Life (QoL) Change | 1 year EQ-5D | 0.08 units on a scale | Standard Deviation 0.26 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Mental | 4.5 units on a scale | Standard Deviation 14.5 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 30 day EQ-5D | 0.07 units on a scale | Standard Deviation 0.3 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ- Clinical | 21.7 units on a scale | Standard Deviation 27.2 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ- Overall | 29.6 units on a scale | Standard Deviation 28.5 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ- Clinical | 23.2 units on a scale | Standard Deviation 28.5 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Physical | 6.4 units on a scale | Standard Deviation 11.4 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Physical | 6.8 units on a scale | Standard Deviation 11.4 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 1 year EQ-5D | 0.08 units on a scale | Standard Deviation 0.27 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 6 month EQ-5D | 0.11 units on a scale | Standard Deviation 0.27 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Mental | 7.9 units on a scale | Standard Deviation 14.9 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Mental | 6.4 units on a scale | Standard Deviation 13.8 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Overall | 19.9 units on a scale | Standard Deviation 29.8 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Clinical | 16.5 units on a scale | Standard Deviation 30.2 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ- Overall | 28.7 units on a scale | Standard Deviation 27.5 |
| Extreme Risk: Non-Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Physical | 5.1 units on a scale | Standard Deviation 10.7 |
| High Risk | Quality of Life (QoL) Change | 30 day KCCQ- Overall | 19.9 units on a scale | Standard Deviation 25 |
| High Risk | Quality of Life (QoL) Change | 1 year SF-12-Mental | 4.7 units on a scale | Standard Deviation 12.3 |
| High Risk | Quality of Life (QoL) Change | 30 day SF-12-Mental | 3.0 units on a scale | Standard Deviation 12.4 |
| High Risk | Quality of Life (QoL) Change | 30 day EQ-5D | 0.05 units on a scale | Standard Deviation 0.21 |
| High Risk | Quality of Life (QoL) Change | 1 year KCCQ- Overall | 27.1 units on a scale | Standard Deviation 24.7 |
| High Risk | Quality of Life (QoL) Change | 6 month EQ-5D | 0.06 units on a scale | Standard Deviation 0.21 |
| High Risk | Quality of Life (QoL) Change | 6 month KCCQ- Overall | 26.2 units on a scale | Standard Deviation 25 |
| High Risk | Quality of Life (QoL) Change | 1 year EQ-5D | 0.05 units on a scale | Standard Deviation 0.21 |
| High Risk | Quality of Life (QoL) Change | 1 year KCCQ- Clinical | 21.0 units on a scale | Standard Deviation 24 |
| High Risk | Quality of Life (QoL) Change | 6 month KCCQ- Clinical | 20.8 units on a scale | Standard Deviation 24.7 |
| High Risk | Quality of Life (QoL) Change | 30 day KCCQ- Clinical | 16.6 units on a scale | Standard Deviation 24 |
| High Risk | Quality of Life (QoL) Change | 6 month SF-12-Physical | 7.1 units on a scale | Standard Deviation 10.7 |
| High Risk | Quality of Life (QoL) Change | 1 year SF-12-Physical | 6.6 units on a scale | Standard Deviation 11.1 |
| High Risk | Quality of Life (QoL) Change | 6 month SF-12-Mental | 4.4 units on a scale | Standard Deviation 11.8 |
| High Risk | Quality of Life (QoL) Change | 30 day SF-12-Physical | 5.7 units on a scale | Standard Deviation 10.2 |
Secondary
Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive
Time frame: 1 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive | 0.8 ratio of days alive and out of hospital | Standard Deviation 0.3 |
| Extreme Risk: Non-Iliofemoral | Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive | 0.7 ratio of days alive and out of hospital | Standard Deviation 0.4 |
| High Risk | Ratio of Days Alive Out of Hospital at 365 Days Post Procedure Versus Total Days Alive | 0.8 ratio of days alive and out of hospital | Standard Deviation 0.3 |
Secondary
Strokes and Transient Ischemic Attacks (TIAs)
Strokes (of any severity) and TIAs
Time frame: 30 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 30 day Stroke | 4.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 6 month TIA | 1.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 6 month Stroke | 6.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 1 year TIA | 2.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 1 year Stroke | 7.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 30 day TIA | 0.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 6 month Stroke | 8.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 30 day Stroke | 5.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 30 day TIA | 0.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 6 month TIA | 0.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 1 year Stroke | 9.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 1 year TIA | 0.9 percentage of participants, Kaplan-Meier |
| High Risk | Strokes and Transient Ischemic Attacks (TIAs) | 30 day Stroke | 4.7 percentage of participants, Kaplan-Meier |
| High Risk | Strokes and Transient Ischemic Attacks (TIAs) | 1 year TIA | 2.9 percentage of participants, Kaplan-Meier |
| High Risk | Strokes and Transient Ischemic Attacks (TIAs) | 1 year Stroke | 8.7 percentage of participants, Kaplan-Meier |
| High Risk | Strokes and Transient Ischemic Attacks (TIAs) | 30 day TIA | 0.7 percentage of participants, Kaplan-Meier |
| High Risk | Strokes and Transient Ischemic Attacks (TIAs) | 6 month Stroke | 6.8 percentage of participants, Kaplan-Meier |
| High Risk | Strokes and Transient Ischemic Attacks (TIAs) | 6 month TIA | 2.2 percentage of participants, Kaplan-Meier |
Secondary
The Occurrence of Individual MACCE Components
Individual MACCE Components Include: * All Cause Mortality * MI * All stroke * 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 day, 6 months, and 1 year. The 2-5 year outcome data will be reported once data set is complete.
Population: Participant Population = Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 1 year All Cause Mortality | 21.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Stroke | 4.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 30 day MI | 1.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 6 month All Cause Mortality | 13.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Reintervention | 0.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Stroke | 7.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 1 year MI | 2.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Reintervention | 0.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 6 month MI | 1.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 30 day All Cause Mortality | 4.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Reintervention | 1.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Stroke | 6.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day All Cause Mortality | 9.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day MI | 1.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year All Cause Mortality | 29.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Reintervention | 1.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year MI | 3.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Stroke | 9.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Stroke | 8.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Stroke | 5.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Reintervention | 0.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month All Cause Mortality | 20.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month MI | 2.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Reintervention | 0.8 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 30 day Reintervention | 0.4 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 30 day MI | 0.4 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 6 month Reintervention | 0.8 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 1 year Reintervention | 0.8 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 30 day Stroke | 4.7 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 30 day All Cause Mortality | 4.9 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 6 month All Cause Mortality | 12.0 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 6 month MI | 1.0 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 6 month Stroke | 7.0 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 1 year All Cause Mortality | 17.8 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 1 year MI | 1.9 percentage of participants, Kaplan-Meier |
| High Risk | The Occurrence of Individual MACCE Components | 1 year Stroke | 8.7 percentage of participants, Kaplan-Meier |