Abbott in 1st Pivotal Trial of New Repair of Leaky Tricuspid Heart Valves

Abbott (NYSE: ABT) today announced the launch of the company’s TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of the company’s TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR). This 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 TR – 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 TR^iv. 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 TR.

The first enrollments in the TRILUMINATE IDE study occurred at Abbott Northwestern hospital in Minneapolis, Minn., led by Paul Sorajja, M.D., and his cardiac team. Dr. Sorajja also serves as the trial co-primary investigator.

“Patients with symptomatic tricuspid regurgitation are often at an increased risk for conventional surgery. As a result, many are not referred for intervention,” said David Adams, M.D., Chairman of the Department of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai and the Cardiac Surgeon-in-Chief of the Mount Sinai Health System and co-primary investigator in the trial. “The opportunity to assess how we can better treat these patients with a minimally invasive approach is critical and  we’re excited about the potential for this therapy in improving the quality of life for these patients.”

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.

https://www.biospace.com/article/releases/abbott-launches-world-s-first-pivotal-trial-to-test-new-approach-for-repairing-leaky-tricuspid-heart-valves/