Study ID: CLASP TR EFS
Edwards PASCAL transcatheter valve repair system in tricuspid regurgitation (CLASP TR) early feasibility study
This study is evaluating the safety and performance of the Edwards PASCAL transcatheter valve repair system (PASCAL System) in patients who have been diagnosed with tricuspid regurgitation (TR). TR, tricuspid insufficiency or tricuspid incompetence, is a condition in which blood flow through the tricuspid valve flows in the incorrect direction during part of the cardiac cycle.
All eligible patients enrolled in this study will have the PASCAL System implanted. Patients are assessed at screening/baseline, procedure, discharge, 30 days, six months, one year and annually for five years post implant procedure.
This prospective, single arm, multi-center, early feasibility study is evaluating the safety and performance of the PASCAL System in the treatment of symptomatic severe tricuspid regurgitation. Safety will be analyzed as a composite endpoint of major adverse events at 30 days.
During the procedure, the PASCAL implant is deployed and secured to the leaflets of the tricuspid valve, acting as a filler in the regurgitant orifice. The PASCAL System percutaneously brings the leaflets together around an intravalvular spacer using independently actuating clasps.
- Must have been diagnosed with severe functional or degenerative TR
- Must not have severe calcification in the annulus or subvalvular apparatus, or moderate to severe calcification or excessive chordae in the grasping area
- Must not have had previous tricuspid valve repair or replacement
- Other inclusion/exclusion criteria apply