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PARADIGM Trial for Adults Needing Heart Valve Replacement
Protocol: STUDY00010118
Full Title
PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR bIomimetic valve designed for physioloGic flow compared to coMmercial TAVR devices
Description
Some adults that have heart valve replacement end up having their new valves fail. This leads them to need surgery to correct the issue. The goal of this study is to see if a new heart valve system is safe and effective for adults that have had their replacement heart valves fail.

Participants will be randomly assigned (which happens by chance, like flipping a coin) to have either the study device or a control device. Following the procedure, participants will have to return to the hospital and have telephone calls to be checked by the doctor or research staff. They will have these follow-up visits 1 month, 6 months, 1 year, and then annually through to 10 years.
Compensation: No
Eligibility
Adults 65 years or older
Have uncontrolled blood pressure
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
DAWN HOLLER
dlh68@buffalo.edu
+1 716-829-6115
COURTNEY BISHOP
cabishop@buffalo.edu
+1 716-888-4859

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