434 Studies Now Enrolling
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:
A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.
