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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130021 S076/ PAS002 |
| Date Original Protocol Accepted |
08/17/2020
|
| Date Current Protocol Accepted |
|
| Study Name |
Low Risk Real World Use Surveillance
|
| Device Name |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Comprehensive/linked/registry-based surveillance. The objective of the surveillance is to assess the real-world use of the CoreValve Evolut R System, CoreValve Evolut PRO System, and Evolut PRO+ System to ensure that the devices are used in appropriate patient population.
|
| Study Population |
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 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. All subjects are followed annually through 10 years post procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Real World Surveillance Low Risk Bicuspid Cohort: 727
|
| Actual Number of Sites Enrolled |
registry based
|
| Patient Follow-up Rate |
registry based
|
| Final Safety Findings |
K-M Adverse Event Rates: All-cause mortality: 1.3% at 30 days; 3.4% at 1 year Any Stroke: 2.6% at 30 days; 3.6% at 1 year Aortic Valve Re-intervention: 1.0% at 30 days; 2.0% at 1 year
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