Evaluation of the Safety and Performance of The Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal access in Patients with Severe, Symptomatic Mitral Regurgitation The Early Feasibility Study of the TMVR Transseptal System
Study of The Medtronic Intrepid Transcatheter Mitral Valve Replacement System in Patients with Severe, Symptomatic Mitral Regurgitation
Sponsor: Medtronic, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAS7963
U.S. Govt. ID: NCT03242642
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition where the blood draws back into the mitral valve causing the heart to pump harder. The population of patients are also those who are not eligible for conventional mitral valve surgery. For participants in this study population, the doctors have deemed the risk of experiencing major complications while undergoing open heart surgery very high due to the current medical conditions or anatomical reasons (relating to how and where the heart, mitral valve, and blood vessels are placed within your body). The study may not provide any direct medical benefits. However, since this population suffers from mitral regurgitation that requires treatment, there may be benefit from the procedure for treatment of mitral regurgitation. Participation in this study is expected to last approximately 5 years from the day participant is implanted. However, participants may be asked to continue follow up for ten years.
Investigator
Susheel Kodali, MD
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366