Trials / Recruiting
RecruitingNCT04097145
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 870 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Detailed description
A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards PASCAL System | Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy |
| DRUG | Optimal Medical Therapy | Optimal Medical Therapy alone in patients with tricuspid regurgitation |
| DEVICE | Edwards PASCAL System | Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT |
| DEVICE | Edwards PASCAL System | Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation |
Timeline
- Start date
- 2019-12-11
- Primary completion
- 2027-12-31
- Completion
- 2031-12-31
- First posted
- 2019-09-20
- Last updated
- 2026-04-06
Locations
79 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04097145. Inclusion in this directory is not an endorsement.