Study ID: CLASP II TR
Edwards PASCAL transcatheter valve repair system pivotal clinical trial
This randomized study is evaluating the Edwards PASCAL transcatheter valve repair system for symptomatic patients with severe tricuspid regurgitation, a condition in which blood flow through the tricuspid valve moves in the incorrect direction during part of the cardiac cycle.
Eligible participants are those at an intermediate or greater estimated risk of mortality if they underwent tricuspid valve surgery.
Patients are randomized into one of two study arms:
- Arm 1 patients undergo transcatheter tricuspid valve repair with the Edwards PASCAL system
- Arm 2 patients proceed with continued medical management of their tricuspid disease (i.e., serial echocardiograms, appropriate medications)
Patient follow-up occurs post-procedure at 30 days, 6 months, and then annually through 5 years.
This is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with severe tricuspid regurgitation.
The primary outcomes being measured are mortality, heart failure hospitalization, need for surgery on the tricuspid valve, and improvement of quality of life.
- Must have been diagnosed with functional or degenerative, severe tricuspid regurgitation
- Must be symptomatic, New York Heart Association (NYHA) class II-IVa or heart failure hospitalization in the prior 12 months
- Must have the appropriate tricuspid valve anatomy to support the implantation of the medical device
- Other significant inclusion and exclusion criteria apply