Trials / Active Not Recruiting
Active Not RecruitingNCT04483089
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device (bRIGHT)
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 511 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The bRIGHT EU PAS study is an observational real-world study evaluating severe tricuspid regurgitation patients treated with the Abbott TriClip™ device (bRIGHT EU Post-Approval Study).
Detailed description
The TriClip™ bRIGHT EU post-approval study (PAS) study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting. The bRIGHT PAS study is a prospective, single arm, open-label, multi-center, post market registry, conducted to satisfy condition of CE Marking for the TriClip™.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter heart valve procedure | Transcatheter treatment of TR with Abbott TriClip™. |
Timeline
- Start date
- 2020-08-27
- Primary completion
- 2027-12-31
- Completion
- 2028-01-01
- First posted
- 2020-07-23
- Last updated
- 2025-01-08
Locations
26 sites across 8 countries: Austria, Denmark, Germany, Italy, Netherlands, Portugal, Spain, Switzerland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04483089. Inclusion in this directory is not an endorsement.