Edwards CLASP TR EFS

Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System

Inclusion Criteria:

• Severe functional or degenerative TR
• Symptomatic despite medical therapy
• The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair

Exclusion Criteria:

• Unsuitable anatomy
• Previous tricuspid valve repair or replacement
• Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study