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Clinical trial

The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.

NCT04408430 is registered in ClinicalTrials.gov with Mayra Guerrero as lead sponsor.

NCT NCT04408430
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Registry record

As filed in ClinicalTrials.gov.

Title
The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.
Lead sponsor
Mayra Guerrero
Phase
Not applicable
Overall status
Recruiting
Start date
March 8, 2021
Completion date
December 31, 2030
Enrollment
210 (estimated)
Sites
17

Conditions

As the registry lists them; a condition with its own page is linked.

mitral annular calcification, mitral regurgitation, mitral stenosis, mitral valve disease