RecruitingNCT07586995
TREAT TR
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
AI Description
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.
- Who can join
- adult, older adult
- Participants
- 1000
- Expected completion
- 2033-08
- Funded by
- industry
Conditions studied
Tricuspid Regurgitation (TR)
What is being tested
- DEVICE: Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
What it measures
- Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points, All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status., At 30-day follow-up
- Rate of Peri-Procedural Adverse Events, Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding, Through 30 days post-procedure
- Tricuspid Regurgitation (TR) grade less than or equal to moderate, At 30-day follow-up
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Registry entry updated 2026-09-02
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.