Edwards Transcatheter Tricuspid Valve Replacement System: Investigation of Safety and Clinical Efficacy using a Novel Device (TRISCEND Study)
Study of the Evoque System in People with Tricuspid Regurgitation (TRISCEND Study)
Sponsor: Edwards Lifesciences
Enrolling: Male and Female Patients
IRB Number: AAAS8957
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 hearts 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 Valve in patients with at least moderate tricuspid regurgitation and signs of, symptoms from or prior heart failure hospitalizations for tricuspid regurgitation. Additionally, to determine the safety and performance of the Edwards EVOQUE Replacement System (EVOQUE System), provide guidance for future clinical study designs using theEVOQUE System, and provide guidance for future EVOQUE System development efforts.
This study is closed
Susheel Kodali, MD
Do You Qualify?
Are you 18 years of age or older? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Kate Dalton