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RecruitMe Clinical Trial

TAVR UNLOAD Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial
Transcatheter Aortic Valve Replacement plus medical management versus medical management alone in patients with ADvanced heart failure
Sponsor:Cardiovascular Research Foundation
Enrolling:Male and Female Patients
IRB Number:AAAQ7433
U.S. Government ID:NCT02661451
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information:

This is a research study to evaluate the use of a device to treat patients with Heart Failure (HF) who have moderate aortic stenosis (AS). The Edwards SAPIEN 3 has already been approved by the FDA for use in patients who require an aortic valve replacement due to severe aortic stenosis. This is an international, multicenter, randomized, open-label, clinical trial comparing the safety and effectiveness of TAVR(Transcatheter Aortic Valve Replacement) with the Edwards SAPIEN 3 THV (transcatheter heart valve) and medical therapy to medical therapy alone in HF patients with moderate AS. You will be randomly (by chance, like flipping a coin) assigned to the TAVR plus medical therapy or the medical therapy alone group.

Do You Qualify?
Are you 18 years or older?YesNo
Do you have severe aortic and/or mitral regurgitation?YesNo
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Investigator
Susheel Kodali, MD
You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Kate Dalton
Email: keb2114@cumc.columbia.edu
Phone: 347-514-3366