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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial — CLASP II TR  

Tricuspid Regurgitation Clinical Trial

Official title:
A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation

Clinical Trial Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Clinical Trial Description

A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04097145
Study type Interventional
Source Edwards Lifesciences
Contact Edwards TMTT Clinical Affairs
Phone (949) 250-2500
Email TMTT_Clinical@edwards.com
Status Recruiting
Phase N/A
Start date December 11, 2019
Completion date March 31, 2029
View Details
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