Active, not recruitingNCT03382457
Clinical Study of Edwards Cardioband FIT Valve Repair System
AI Description
Clinical Study of the Edwards Cardioband FIT Repair System
- Who can join
- adult, older adult
- Participants
- 75
- Expected completion
- 2031-12-31
- Funded by
- industry
Conditions studied
Tricuspid Regurgitation
What is being tested
- DEVICE: Transcatheter Tricuspid Valve Repair
What it measures
- Primary Performance Endpoint - Clinical Success, Number of patients who had Clinical Success at 30 days and 1 year, definition modified from TVARC criteria. Per patient analysis., 30 days and 1 year
- Primary Performance Endpoint - Intraprocedural Success, Number of patients who had Intraprocedural Success, definition modified from TVARC criteria. Per patient analysis., Intraprocedural
- Primary Safety Endpoint -Composite Major Adverse Event (MAE) Rate, Number and percentage of patients who experienced at least one major adverse event (MAE)., 30 days
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
Intermountain Medical Center
Murray, UT
Lankenau Medical Center
Wynnewood, PA
Mayo Clinic (Rochester, Minnesota)
Rochester, MN
Morristown Medical Center
Morristown, NJ
Northwestern Memorial Hospital
Chicago, IL
OHSU Hospital
Portland, OR
University Medical Center
Charlottesville, VA
Registry entry updated 2026-05-08
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.