The Safety and Effectiveness of the SAPIEN 3 and SAPIEN 3 Ultra Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves). (MITRAL-II)
Sponsor: Edwards Lifesciences
Enrolling: Male and Female Patients
IRB Number: AAAT6185
U.S. Govt. ID: NCT04408430
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to calcium deposit associated with aging or kidney disease) and who are not candidates for standard mitral valve surgery.
Investigator
Isaac George, MD
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366
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