Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device
TRISCEND ll PIVOTAL Study of the Edwards EVOQUE Tricuspid Valve Replacement System
Sponsor: Edwards Lifesciences
Enrolling: Male and Female Patients
Clinic Visits: 7
IRB Number: AAAT2480
U.S. Govt. ID: NCT04482062
Contact: Parisha Masud: 347-514-3366 / pm3075@cumc.columbia.edu
Additional Study Information: This is a prospective, single-arm, multi-center, early feasibility study. This research study is 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 evaluate the safety and performance of the Evoque system with Optimal Medical Therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation (TR). Participants will be evaluated for clinical follow-up at the following intervals: discharge, 30 days, 6 months, 12 months and annually thereafter for 5 years post-procedure.
Investigator
Susheel Kodali, MD
Do You Qualify?
Are you 18 years or older? Yes No
Are you willing to return to Columbia University Medical Center for all research required follow up visits? Yes No
Have you had a stroke within the last 60 days? Yes No
Have you had previous surgery on your tricuspid valve? Yes No
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For more information, please contact:
Parisha Masud
pm3075@cumc.columbia.edu
347-514-3366