Trials / Active Not Recruiting
Active Not RecruitingNCT04614402
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System
Transcatheter Repair of Tricuspid Regurgitation With Edwards PASCAL Transcatheter Valve Repair System: A European Prospective, Multicenter Post-Market Clinical Follow up
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter tricuspid valve repair.
Detailed description
The objectives of this clinical study are to collect data on the safety and effectiveness of the PASCAL System and PASCAL Precision System in improving TR, functional status, and quality of life in a post-market setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards PASCAL Transcatheter Valve Repair System | The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve. |
| DEVICE | Edwards PASCAL Precision Transcatheter Valve Repair System | The Edwards PASCAL Precision Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve. |
Timeline
- Start date
- 2021-01-15
- Primary completion
- 2023-04-20
- Completion
- 2028-03-15
- First posted
- 2020-11-04
- Last updated
- 2025-07-02
Locations
15 sites across 4 countries: Germany, Greece, Italy, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04614402. Inclusion in this directory is not an endorsement.