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.
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 |
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
Are you 18 years or older? |
Yes |
No |