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Clinical Trial Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)


Clinical Trial Description

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT) Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03706833
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 November 30, 2018
Completion date April 30, 2030

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