TriCLASP PMCF Study

Transcatheter Repair of Tricuspid Regurgitation with Edwards PASCALTranscatheter Valve Repair System: A European prospective,multicenter Post‐Market Clinical Follow up

22/01/2021 to 30/06/2027

Hypothesis
The Edwards PASCAL Transcatheter Valve Repair System will reduce the
severity of tricuspid regurgitation (TR) at discharge, with durable
performance at 12 months and improvements in functional status as
determined by changes in 6MWT, NYHA classification and quality of life.
Study
Objectives
The objectives of this clinical study are to collect data on the safety and
effectiveness of the PASCAL System in improving TR, functional status,
and quality of life in a post‐market setting.
Study Design
and Methods
Multi‐center single arm prospective study. Patients will be followed for up
to 5 years.