Trials / Active Not Recruiting
Active Not RecruitingNCT04482062
TRISCEND II Pivotal Trial
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 864 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
Detailed description
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.
Conditions
- Tricuspid Valve Regurgitation
- Tricuspid Valve Insufficiency
- Tricuspid Valve Disease
- Heart Valve Diseases
- Cardiovascular Diseases
- Heart Failure
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards EVOQUE System | Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT |
| DRUG | Optimal Medical Therapy | Optimal Medical Therapy |
Timeline
- Start date
- 2021-04-09
- Primary completion
- 2025-12-05
- Completion
- 2030-06-27
- First posted
- 2020-07-22
- Last updated
- 2026-02-27
Locations
62 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04482062. Inclusion in this directory is not an endorsement.