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TRILUMINATE Tricuspid Regurgitation Heart Failure Study
Protocol: SITE00000149
Full Title
Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal
Description
This study enrolls people who have been diagnosed with Tricuspid Regurgitation (TR) and have Heart Failure symptoms which are not under control despite treatment with current available therapies. The purpose of this study is to compare a new investigational (experimental) device plus optimal drug therapy with optimal drug therapy alone.

This study will last 5 years. There will be follow ups at 1, 6, 12, and 18 months, then 2, 3, 4, and 5 years. The first visit will consist of a physical exam, imaging of the heart, and bloodwork collection. After speaking with you and looking at the lab work, if your cardiologist thinks this may still be of benefit to you, you may move forward to enroll in the study. This procedure involves a small device being implanted into your heart. A small cut is made in your groin where your doctor can access the large vein in your leg. The device can enter this vein on a wire, which can then be guided up to your heart where it will be placed. This is the least invasive way of getting into the heart. This study takes place at Buffalo General Medical Center, Gates Vascular Institute, and UBMD Outpatient Clinics in Buffalo NY.
Compensation: No
Eligibility
Adults ages 18+
Diagnosed with moderate or greater Tricuspid Regurgitation/Insufficiency with Heart Failure symptoms
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
COURTNEY BISHOP
cabishop@buffalo.edu

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