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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P130021 S033/ PAS002 |
| Date Original Protocol Accepted |
04/09/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
Intermediate Risk Surveillance
|
| Device Name |
CoreValve System; CoreValve Evolut R System; CoreValve 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. This is prospective, non-randomized study.
The purpose of the surveillance plan is to utilize the TVT Registry to evaluate longer term the safety and device performance of the Medtronic TAVR for intermediate risk patients with symptomatic severe native aortic stenosis for 2 years following device approval. Annual clinical summaries will report long term follow-up and monitor adverse events (as collected through the TVT-R and CMS claims data) through 5 years post implant.
|
| Study Population |
Patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).
|
| Sample Size |
Subjects with an attempted implant of Medtronic TAVR within 2 years of approval for intermediate surgical risk and entered in the TVT-R from participating sites.
|
| Key Study Endpoints |
Intra-procedure
Device success
At 30 days and 12 months:
All-cause mortality
All stroke
Life threatening/Major bleeding
New requirement for dialysis
Peri-procedural myocardial infarction
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Neurological (Non-stroke)
Vascular complications
Quality of life (KCCQ) outcomes At 2 – 5 years post-implantation:
All-cause mortality
All stroke
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
|
| Follow-up Visits and Length of Follow-up |
5 year post implantation.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
12,596 TVT-R intermediate risk patients; 10,381 subjects were uniquely matched with the CMS claims and encounter data
|
| Actual Number of Sites Enrolled |
registry based
|
| Patient Follow-up Rate |
Overall Study Compliance Rate: Of 12,595 TVT-R intermediate risk patients, 10,381 subjects were uniquely matched with the CMS data.
|
| Final Safety Findings |
Overall TVT-R/CMS Matched Population Event Rates at 2 Years: All-Cause Mortality: 15.9%, Any Stroke: 7.1%, Aortic Valve Reintervention: 0.8%
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