TRILUMINATE Tricuspid Regurgitation Heart Failure Study
Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal
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.
The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR) who have been determined by the site???s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery.
Adults ages 18+
Diagnosed with moderate or greater Tricuspid Regurgitation/Insufficiency with Heart Failure symptoms
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 firstname.lastname@example.org and someone will assist you.
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assurance and will remain confidential. Your information will be stored indefinitely. Should you no longer want this information to be provided
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