Status:
ACTIVE_NOT_RECRUITING
An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClip™ Device (bRIGHT)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Tricuspid Valve Regurgitation
Eligibility:
All Genders
18+ years
Brief 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 prospect...
Eligibility Criteria
Inclusion
- Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- Subjects eligible to receive the TriClip™ per the current approved Indications for Use.
- Subject must provide written informed consent prior to study procedure.
Exclusion
- 1\. Subjects participating in another clinical study that may impact the follow-up or results of this study.
Key Trial Info
Start Date :
August 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT04483089
Start Date
August 27 2020
End Date
January 1 2028
Last Update
January 8 2025
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Universitätsklinik Graz
Graz, Austria
2
Odense University Hospital
Odense, Denmark
3
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany, 53127
4
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Rhineland-Palatinate, Germany, 55131