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STAR Trial for Patients Needing TAVR Procedures
Protocol: STUDY00010197
Full Title
STAR Trial (Siegel Transcatheter Aortic Valve Replacement in patients with symptomatic severe aortic stenosis)
Description
Many patients with aortic stenosis (AS) have surgery to replace the heart valve that is not working properly. However, surgical options always have higher risk than non-surgical options. Doctors are interested in developing a non-surgical way to replace heart valves in patients with AS.

A research team from the University at Buffalo is participating in the multi-site STAR trial. The goal of this study is to see if a new non-surgical procedure can properly replace heart valves in patients with AS.

This study will last for 10 years. Participants will have the either the study device (the Siegel TAVR system) or the normal standard of care (TAVR system) placed in their hearts via a small cut made in the groin. A thin flexible tube will guide the heart valve into the heart. It will then be placed within the aortic valve. Participants will have follow-up visits 30 days and then yearly for 10 years after the procedure. They will have physical exams, blood work, surveys, walk tests, and imaging tests.

Participants will be paid $50 for each in-person study visit.
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 18 years or older
Have been diagnosed with aortic stenosis
Are in need of aortic valve replacement
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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