Evaluation of the Safety and Performance of the Half Moon Transcatheter Mitral Valve Repair System in High-Risk Patients with Severe, Symptomatic Mitral Regurgitation - The Half Moon TMVr Pilot Study
The Half Moon Transcatheter Mitral Valve Repair (TMVr) Study
Sponsor: Half Moon Medical, Inc.
Enrolling: Male and Female Patients
Study Length: 5 Years
IRB Number: AAAT2507
U.S. Govt. ID: NCT04343313
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This Early Feasibility Study (EFS) is looking at the investigative device called the Half Moon TMVrSystem to see if it is safe and effective in treating patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery. The system is designed so that a catheter can gain access to the heart by way of a large artery in the leg or by a small surgical passage through the walls between the right and left chamber of the heart. The implant then anchors on the leaflets of the valve in a certain manner. The Transcatheter Mitral Valve Replacement system functions only allowing the flow of blood in one direction thus, preventing any leakage back into the mitral valve during left ventricle contraction. The TMVR System provides the same treatment as that of the standard valve implant used during conventional mitral repair but using a less invasive approach. Patients will be expected to return for follow-up visits at 1, 3, 6 and 12 months, and every 6 months through 5 years.
Susheel Kodali, MD
Do You Qualify?
Have you been diagnosed with mitral regurgitation? Yes No
Have you had previous mitral valve surgery? Yes No
Do you have COPD and require continuous oxygen at home? Yes No
Are you currently in renal failure requiring dialysis? Yes No
Do you have a organ transplant or being evaluated for one? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Kate Dalton