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New Clinical Trial Evaluates Cardiovascular Outcomes in Tricuspid Valve Repair Without Open Heart Surgery

July 27, 2021
by Elisabeth Reitman

Investigators at the Yale School of Medicine are participating in an international study to evaluate the clinical outcomes of TriClip, the first non-surgical minimally invasive tricuspid valve repair device developed by Abbott.

The TRILUMINATE Pivotal Trial will enroll 700 participants from 81 different sites across the U.S., as well as several sites in Canada and Europe. The Heart and Vascular Center at Yale New Haven Hospital is the first in Connecticut to offer this minimally invasive therapy for tricuspid regurgitation (TR). The trial’s primary outcome measure is one-year mortality and hospitalization rates among those who receive the TriClip device. The study will also examine improvement in patient symptoms and quality of life following the procedure.

Moderate or severe tricuspid regurgitation (TR) is estimated to affect 1.6 million adults in the U.S., according to the Journal of Thoracic and Cardiovascular Surgery. Tricuspid regurgitation is diagnosed using an echocardiogram, and patients with TR are often older and high-risk candidates for open-heart surgery. Symptoms from tricuspid regurgitation include shortness of breath, fatigue, and swelling in the legs and abdomen.

Treatment options for valvular heart disease have been limited in the past, but over the last decade, the cardiology community has seen the rapid development of revolutionary catheter-based treatments. Ryan Kaple, MD, an assistant professor of medicine, is the site principal investigator on the TRILUMINATE trial at Yale and is recognized as a national leader in valvular heart disease.

“It has been an exciting time to practice interventional cardiology. The ability to replace and repair heart valves without open-heart surgery has transformed our practice and the patient experience. Currently there are very few treatment options for tricuspid regurgitation, which is why there is a great deal of excitement around this study. I am very pleased that our patients with tricuspid regurgitation will now have access to this safe and minimally invasive treatment through the trial,” Kaple said.

The Structural Heart Program at Yale is also engaged in the management of patients with a variety of other structural cardiac abnormalities including: mitral valve repair, mitral valve replacement, aortic valve replacement, and catheter-based treatments for heart failure. For more information about the Yale Structural Heart Disease Program, please visit cardiology.yale.edu.

If you have a patient with tricuspid valve disease who you would like evaluated, you can contact the Structural Heart Clinic at 203-785-7990 or contact Dr. Kaple directly at ryan.kaple@yale.edu.

Submitted by Elisabeth Reitman on July 27, 2021