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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P230013 / PAS001 |
| Date Original Protocol Accepted |
02/01/2024
|
| Date Current Protocol Accepted |
|
| Study Name |
Registry-Based Real-World Use Surveillance
|
| Device Name |
Edwards EVOQUE Tricuspid Valve Replacement System
|
| Clinical Trial Number(s) |
NCT04482062
|
| 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 |
Registry-Based Real-World Use Surveillance. The objective of the surveillance is to assess the real-world performance of the EVOQUE system and the clinical outcomes of the device in patient populations underrepresented in the TRISCEND II pivotal trial.
|
| Study Population |
Patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, for whom tricuspid valve replacement is deemed appropriate by a heart team.
|
| Sample Size |
All consecutive patients treated within the first 2 years following device approval or a total of 5,000 consecutively treated patients, whichever is greater, who are entered into the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry (enrollment period). Data collection will continue for underrepresented racial and ethnic groups (Black/African American, Asian, American Indian/Alaskan Native, Native Hawaiian/Pacific Islander, and Hispanic or Latino ethnicity) until each group has enrolled a minimum of 100 patients.
|
| 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, tricuspid valve reintervention, 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
All-cause death: 30 days, 3.9%;
All stroke: 30 days, 0.8%;
Tricuspid valve re-intervention (percutaneous or surgical): 30 days, 0.8%;
All-cause hospitalization: 30 days, 12.1%;
Heart failure hospitalization: 30 days, 4.1%;
Life-threatening or major bleeding events: 30 days, 0.0%
New conduction disorder/disturbance requiring a permanent pacemaker: 30 days, 7.1%
Effectiveness Results
Moderate/Severe Tricuspid Regurgitation: baseline, 100%; 30 days, 5.2%;
Kansas City Cardiomyopathy Questionnaire Overall Summary score: baseline 41.6 +/- 25.5; 30 days, 67.7 +/- 24.8;
New York Heart Association Functional Classification III/IV: baseline, 77%; 30 days, 25.9%
|
| Actual Number of Patients Enrolled |
138
|
| Actual Number of Sites Enrolled |
27
|
| Patient Follow-up Rate |
All 128 patients had a known 30-day follow-up status, including 112 patients with a completed visit (91% of alive patients). At 30-day follow-up, there were 5 reported patient deaths and 11 patients who had not completed a visit but were alive through 30 days.
At 1-year follow-up, 8 patients had known status, all of whom died. The remaining 120 patients had pending 1-year visits.
Table 3-2 of the report provides the patient disposition data.
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