|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P220003 / PAS002 |
| Date Original Protocol Accepted |
09/14/2022
|
| Date Current Protocol Accepted |
|
| Study Name |
Registry-Based Real-World Use Surveillance
|
| Device Name |
PASCAL Precision Transcatheter Valve Repair System
|
| Clinical Trial Number(s) |
NCT03706833
|
| General Study Protocol Parameters |
| Study Design |
Active 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 objective of the surveillance is to assess the real-world performance of the PASCAL Precision system.
|
| Study Population |
The surveillance 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 are collected through the TVT Registry. The follow-up data (including all-cause mortality, stroke, repeat procedure for mitral valve-related dysfunction, and hospitalization) from year 2 through year 5 post procedure are obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
TVT registry:
Device implanted successfully: 97.6%
At 30 Days:
All-cause death: 2.3%
All stroke: 1.3%
Mitral valve re-intervention: 0.3%
All-cause hospitalization: 8.9%
Heart failure hospitalization: 2.6%
Single leaflet device attachment: 0.5%
Major or life-threatening bleed: 1.4%
At 1 Year:
All-cause death: 9.7%
All stroke: 2.1%
Mitral valve re-intervention: 1.8%
All-cause hospitalization: 24.5%
Heart failure hospitalization: 7.6%
Medicare-Linked TVT registry:
Device implanted successfully: 99.8%
At 1 Year:
All-cause death: 17.5%
All stroke: 2.4%
Mitral valve re-intervention: 3.7%
All-cause hospitalization: 44.7%
Heart failure hospitalization: 11.9%
Effectiveness Results:
TVT registry:
Mitral Regurgitation (Greater than Moderate-Severe):
100% (Baseline); 6.4% (30 Days)
KCCQ (Overall Score):
Change from baseline to 30-day visit: 21.6
Change from baseline to 1-year visit: 23.8
NYHA Class:
Improved or stayed the same at 30-day visit: 96.7%
Improved or stayed the same at 1-year visit: 96.9%
|
| Actual Number of Patients Enrolled |
2411 patients (TVT registry)
524 (Medicare-linked TVT registry)
|
| Actual Number of Sites Enrolled |
199 sites
|
| Patient Follow-up Rate |
Patient status known (TVT registry):
At 30 days: 92.6%
At 1 year: 52.2%
Patient status known (Medicare-linked TVT registry):
At 1 year: 14.7%
|
