Trials / Active Not Recruiting
Active Not RecruitingNCT03904147
TRILUMINATE Pivotal Trial
Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System Pivotal
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 572 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TriClipTM Device | Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation |
Timeline
- Start date
- 2019-08-21
- Primary completion
- 2022-11-18
- Completion
- 2029-04-01
- First posted
- 2019-04-05
- Last updated
- 2024-12-19
- Results posted
- 2024-03-27
Locations
76 sites across 5 countries: United States, Canada, Germany, Italy, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03904147. Inclusion in this directory is not an endorsement.