NCT03745313

Edwards CLASP TR EFS

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Edwards PASCAL Transcatheter Valve Repair System	Repair of the tricuspid valve through a transcatheter approach

Timeline

• Start date: 2019-02-05
• Primary completion: 2021-05-11
• Completion: 2025-05-13
• First posted: 2018-11-19
• Last updated: 2025-09-29
• Results posted: 2024-10-09

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study