Tenet Healthcare Corporation | Delray Medical Center
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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.
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This is a prospective single-arm, multicenter study.
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Interventional model
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900 participants in 3 patient groups
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Edwards THV Clinical Affairs
Data sourced from clinicaltrials.gov
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