Evaluation of the Safety and Performance of The Medtronic Intrepid Transcatheter Tricuspid Valve Replacement (TTVR) System with Transfemoral access in Patients with symptomatic severe tricuspid regurgitation -The Early Feasibility Study of the TTVR Transfemoral System
TTVR Early Feasibility Study in Patients with Symptomatic Severe Tricuspid Regurgitation - Medtronic
Sponsor: Medtronic, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAT2468
U.S. Govt. ID: NCT04433065
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward. The goal of this study is to gain early clinical insight into the how the Intrepid transcatheter tricuspid valve replacement (TTVR) system device performs. There is a need for alternative and less invasive treatment options to treat this condition. The Intrepid TTVR implant is intended to be placed through a less invasive procedure as compared to procedures conducted with open-heart surgery such as incisions through the chest wall and opening the chest cavity to access the heart.
Investigator
Susheel Kodali, MD
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366