By Donna Loyle, communications manager, LIMR
Main Line Health is participating in a randomized, controlled pivotal study that is evaluating the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with severe tricuspid regurgitation.
Eligible participants are those at an intermediate or greater estimated risk of mortality if they underwent tricuspid valve surgery. The primary outcomes being measured are mortality, heart failure hospitalization, need for surgery on the tricuspid valve, and improvement of quality of life.
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, six months, and then annually through five years.
- 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 implantation of the medical device
- Other significant inclusion and exclusion criteria apply
The MLH principal investigator for the CLASP II TR clinical trial is William Gray. The trial is approved for Lankenau Medical Center.