Mitral Regurgitation Clinical Trial
Official title:
SAPIEN M3 System Transcatheter Mitral Valve Replacement Via Transseptal Access
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.
This is a prospective single-arm, multicenter study. ;
Status | Clinical Trial | Phase | |
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Completed |
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Completed |
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Completed |
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Completed |
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Recruiting |
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Completed |
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Suspended |
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Phase 2 |