Minneapolis Heart Institute Foundation®Enrolls Patient in World’s First Pivotal Trial Testing New Approach for Repairing Leaky Tricuspid Heart Valves
TRILUMINATE Pivotal trial is the randomized clinical trial to evaluate transcatheter tricuspid valve repair using Abbott’s TriClip system in patients with severe tricuspid regurgitation
MINNEAPOLIS, Minn., Sept. 5, 2019 – Minneapolis Heart Institute Foundation®(MHIF) today announced it enrolled the first patient, completing the first successful implant, as part of a pivotal clinical trial that is evaluating a new treatment option for patients with severe tricuspid regurgitation (leaky tricuspid heart valve). The TRILUMINATE Pivotal clinical trial is the first pivotal Investigational Device Exemption (IDE) trial in the U.S. to evaluate a catheter-based, non-surgical treatment for patients with severe tricuspid regurgitation.
The study is evaluating Abbott’s TriClip tricuspid valve repair system, which is built on the MitraClip system, a technology that is approved and available for the treatment of mitral valve regurgitation. MHIF is a leader in research to advance treatments for heart valve disease and was also involved in studies that were used to gain regulatory approval for the MitraClip system.
“In the last few years, new treatments for heart valve disease have significantly improved options and outcomes for patients with the debilitating symptoms from aortic and mitral valve disease and transcatheter tricuspid valve repair is the new frontier,” said Paul Sorajja, MD, Roger L. and Lynn C. Headrick Chair for Valve Science Research at MHIF and co-primary investigator for the TRILUMINATE Pivotal trial. “This new study will be important in evaluating a technology approach for patients who are in need of treatment of for tricuspid regurgitation and likely have few options as their disease potentially progresses to heart failure.”
Tricuspid regurgitation is a condition in which the valve doesn’t close properly, allowing blood to flow backward into the heart, which forces the heart to work harder. In severe cases, this condition can potentially lead to heart failure if left untreated.i.ii.iii
In the U.S. alone, approximately one in 30 people over the age of 65 have moderate to severe tricuspid regurgitation. Despite the prevalence of tricuspid valve disease, the tricuspid valve is often referred to as the “forgotten heart valve” as treatment options are limited. There are currently no approved non-surgical, minimally invasive treatments for people with severe tricuspid regurgitation.
The TRILUMINATE Pivotal study is a prospective, multi-center, randomized, controlled global study of approximately 700 patients expected to enroll in the United States, Canada, and Europe. Patients will be randomized to receive either the TriClip device or medical therapy and followed for a total of five years. The study will also have a single arm for the treatment of subjects with more complex tricuspid valve disease.
About the Minneapolis Heart Institute Foundation®
The Minneapolis Heart Institute Foundation (MHIF) strives to create a world without heart and vascular disease. To achieve this bold vision, it is dedicated to improving the cardiovascular health of individuals and communities through innovative research and education.
- Scientific Innovation and Research — MHIF is a recognized research leader in the broadest range of cardiovascular medicine and population health initiatives. Each year MHIF leads more than 175 active research projects and publishes more than 175 peer-reviewed abstracts. Cardiologists, hospitals and communities around the world adopt MHIF protocols to save lives, improve care and create healthier living opportunities.
- Education and Outreach — MHIF provides more than 10,000 hours of education each year putting its research into practice to improve outcomes. And, MHIF leads cutting-edge, transformative population health research to connect, engage, inform and empower individuals and communities to improve their health.
The Minneapolis Heart Institute Foundation’s work is funded by generous donors and sponsors and supports research initiatives of Minneapolis Heart Institute® at Abbott Northwestern Hospital. Minneapolis Heart Institute® physicians provide care for patients at Abbott Northwestern Hospital in Minneapolis and at 38 community sites across Minnesota and western Wisconsin. More information can be found at http://www.mplsheart.org
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i Singh JP, Evans JC, Levy D , et al . Prevalence and clinical determinants of mitral, tricuspid, and aortic regurgitation (the Framingham Heart Study). Am J Cardiol 1999;83:897–902.doi:10.1016/S0002-9149(98)01064-9.
ii Vassileva CM , Shabosky J , Boley T , et al . Tricuspid valve surgery: the past 10 years from the Nationwide Inpatient Sample (NIS) database. J Thorac Cardiovasc Surg 2012;143:1043–9.doi:10.1016/j.jtcvs.2011.07.004.
iii Stuge O , Liddicoat J . Emerging opportunities for cardiac surgeons within structural heart disease. J Thorac Cardiovasc Surg 2006;132:1258–61.doi:10.1016/j.jtcvs.2006.08.049.