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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140031 S125/ PAS001 |
| Date Original Protocol Accepted |
05/13/2021
|
| Date Current Protocol Accepted |
|
| Study Name |
SAPIEN 3 & SAPIEN 3 Ultra Mitral ValveInRing Surv
|
| Device Name |
SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
|
| 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 continue to monitor the performance of the Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System in the real-world setting.
|
| Study Population |
Patients with symptomatic heart disease due to failing of a native mitral valve with an annuloplasty ring who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).
|
| Sample Size |
All consecutive patients treated within the first 5 years after the PMA approval that are entered into the TVT Registry.
|
| Key Study Endpoints |
(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; and (3) neurological (non-stroke), vascular complications, and quality of life (KCCQ) outcomes at 30 days and 12 months.
|
| Follow-up Visits and Length of Follow-up |
1 year
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Procedural Outcomes: Device implanted successfully: 89.9% (241/268); Conversion to open heart surgery: 1.1% (3/268); 1 ventricular rupture; 3 cardiac tamponade. 30 day safety outcomes: All-cause death: 9.2%, All stroke: 0.8%, Life threatening/major bleeding: 1.2%, New requirement for dialysis: 2.0%, Mitral valve reintervention: 1.2%, Vascular complications: 5.0%; 1 year safety outcomes: All-cause death: 28.8%, All stroke: 2.3%, Life threatening/major bleeding: 7.8%, New requirement for dialysis: 6.3%, Mitral valve reintervention: 6.9%, Vascular complications: 5.8%
Effectiveness Results:
30 day effectiveness outcomes: Mild or less mitral regurgitation was present in 96.6% of available patients. There was moderate or less paravalvular leak (PVL) in 97.4% of patients. The mean mitral gradient decreased from 8.7 mmHg at baseline to 7.6 mmHg. Mean mitral valve area was 2.03 cm2 at baseline and 1.97 cm2 at 30 days. NYHA: 70.5% of patients improved from baseline to 30-day visit. The mean KCCQ Overall Summary Score improved from 44.1 at baseline to 70.4 at 30 days. 1 year effectiveness outcomes: Mild or less mitral regurgitation was present in 97% of available patients. There was moderate or less paravalvular leak (PVL) in 95.9% of patients. The mean mitral gradient decreased from 8.7 mmHg at baseline to 8.3 mmHg. Mean mitral valve area was 2.05 cm2 at baseline to 1.88 cm2. NYHA: 71.9% of patients improved from baseline to 1-year visit. The mean KCCQ Overall Summary Score improved from 43.1 at baseline to 73.3 at 1-year.
|
| Actual Number of Patients Enrolled |
268 patients (Attempted Implant); 265 patients (valve implanted)
|
| Actual Number of Sites Enrolled |
144
|
| Patient Follow-up Rate |
30 days: 97%
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