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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130021 S058/ PAS002 |
| Date Original Protocol Accepted |
08/16/2019
|
| Date Current Protocol Accepted |
03/20/2020
|
| Study Name |
Evolut R and PRO Sys Registry-Based Low Risk RWU
|
| Device Name |
Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Comprehensive/linked/registry-based surveillance. The objectives of the surveillance are to characterize the clinical outcomes of the CAP cohort annually through 10 years post implantation and to assess the real-world use of the commercial Medtronic CoreValve Evolut R System and CoreValve Evolut PRO System to ensure that the device is used in appropriate circumstances.
|
| Study Population |
The surveillance of the CAP cohort will consist of all living CAP patients who were enrolled at participating institutions, and the surveillance of the real-world use will involve all consecutive patients treated within the first 2 years that are entered into the TVT Registry (enrollment period)
|
| Sample Size |
All living CAP subjects and all consecutive patients treated within the first 2 years in the commercial setting that are entered into the TVT Registry.
|
| Key Study Endpoints |
The clinical data through one (1) year will be collected through the TVT Registry; and the follow-up data from year 2 through year 10 post procedure will be obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database. The surveillance will monitor the following: (1) device success (intra-procedure); (2) all-cause mortality, all stroke, life-threatening/major bleeding, new requirement for dialysis, peri-procedural myocardial infarction, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 30 days and 12 months; (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months; and (4) all-cause mortality, all stroke, and repeat procedure for valve-related dysfunction (surgical or interventional therapy) at 2-10 year post implantation.
|
| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Real World Surveillance Low Risk Cohort: 7,440
Low Risk CAP Cohort: 745
|
| Actual Number of Sites Enrolled |
registry based
|
| Patient Follow-up Rate |
registry based
|
| Final Safety Findings |
Real World Surveillance Low Risk Cohort K-M Adverse Event Rates: All-cause mortality: 1.2% at 30 days; 5.1% at 1 year Any Stroke: 2.6% at 30 days; 3.6% at 1 year Life-threatening/major bleeding: 4.0% at 30 days; 4.9% at 1 year
Vascular Complication: 3.7% at 30 days; 4.0% at 1 year New requirement for dialysis: 0.2% at 30 days; 0.3% at 1 year Myocardial infarction: 0.3% at 30 days; 1.1% at 1 year Aortic Valve Re-intervention: 0.4% at 30 days; 0.7% at 1 year Low Risk CAP Cohort K-M Adverse Event Rates: All-cause mortality: 0.7% at 30 days; 2.3% at 1 year Any Stroke: 2.7% at 30 days; 3.6% at 1 year Life-threatening/major bleeding: 3.4% at 30 days; 3.8% at 1 year Vascular Complication: 2.8% at 30 days; 3.1% at 1 year New requirement for dialysis: 0.0% at 30 days; 0.1% at 1 year Myocardial infarction: 0.1% at 30 days; 0.5% at 1 year Aortic Valve Re-intervention: 0.3% at 30 days; 0.8% at 1 year
|
| Final Effect Findings |
KCCQ: Real World Surveillance Low Risk Cohort: Change from Baseline to 1-Month at 30 days: 25.7 + 24.3 Change from Baseline to 1-Month at 1-Year: 27.5 + 23.9 Low Risk CAP Cohort: Change from Baseline to 1-Month at 30 days: 21.3 + 23.0 Change from Baseline to 1-Month at 1-Year: 24.7 + 22.8
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