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Clinical Trial Summary

This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.


Clinical Trial Description

This is a prospective single-arm, multicenter study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04153292
Study type Interventional
Source Edwards Lifesciences
Contact Edwards THV Clinical Affairs
Phone +1 (949) 250-2500
Email THV_CT.gov@Edwards.com
Status Recruiting
Phase N/A
Start date November 12, 2020
Completion date February 2031

See also
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