Study for Device to Treat Severe Aortic Stenosis
Protocol: STUDY00002001
Full Title
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
Description
This study enrolls seniors with severe aortic stenosis. The purpose of this study is to find out whether aortic valve replacement is helpful for patients
who have severe aortic stenosis (a narrowing of the aortic heart valve) and no symptoms The study looks at this by testing an artificial heart valve.

If you and your doctor decide you will participate in the study, you will be randomized (like the flip of a coin) into one of two groups. Some people will have a procedure to replace their aortic valve. Other people will not have the valve replacement procedure and will receive optimum medical therapy and be watched closely to see how they are doing. You will be in this study for about 5-10 years. Study takes place at Gates Vascular Institute, 875 Ellicott St. Buffalo, NY 14203.

Compensation will be provided.

Technical Description

(CSR#171008749402 ) This study is for people 65yrs old or greater that have severe aortic stenosis. In order to participate, you must be considered asymptomatic after a screening treadmill stress test. The goal of the study is to compare the safety and effectiveness of the Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, California) Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis. The Edwards SAPIEN 3 heart valve is commercially available. Follow up for this study will last for 5 years.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
-Adults ages 65+.
-Recently diagnosed with severe, calcific, aortic stenosis without any symptoms.
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
COURTNEY BISHOP
cabishop@buffalo.edu
HEIDI NIEVES-MCGRATH
hnievesm@buffalo.edu
+1 716-888-5853
Want to Learn More?
Enrollment Update

Due to COVID-19, new enrollment in research studies will be greatly limited. If you are interested in a study, there may be a longer waiting period to receive a response to your inquiry. View the guidance for research participants for additional information.

Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.