TRILUMINATE Pivotal Trial Begins for Abbott's TriClip Transcatheter Tricuspid Valve Repair System

September 5, 2019—Abbott announced the commencement of the 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).

The TRILUMINATE pivotal study is a prospective, multicenter, randomized, controlled, global study composed of approximately 700 patients expected to be enrolled in the United States, Canada, and Europe. In the United States, the trial is being conducted under an investigational device exemption (IDE) from the FDA. Patients will be randomized to receive either the TriClip device or medical therapy and followed for a total of 5 years. The study will also have a single arm for the treatment of patients with more complex tricuspid valve disease.

The first enrollments in the TRILUMINATE IDE study occurred at Abbott Northwestern Hospital in Minneapolis, Minnesota, and was led by Paul Sorajja, MD, and his cardiac team. Dr. Sorajja also serves as the trial Coprimary Investigator.

David Adams, MD, Coprimary Investigator, commented in the company’s announcement, “Patients with symptomatic TR are often at an increased risk for conventional surgery. As a result, many are not referred for intervention. 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.” Dr. Adams is 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 in New York, New York.

Abbott advised that alongside the TRILUMINATE study, the TriClip device was accepted for national reimbursement consideration by the FDA and the Centers for Medicare & Medicaid Services through the “Parallel Review” program, a collaborative effort that is intended to reduce the time between FDA approval and Medicare coverage decisions through the National Coverage Determination process.

The launch of the pivotal TRILUMINATE IDE study follows a smaller, single-arm TRILUMINATE trial that was conducted in Europe and the United States to evaluate the safety and performance of the TriClip repair system.

Results from the smaller study were presented during a late-breaking session at EuroPCR 2019, held May 21–24 in Paris, France. The study found that after 30 days, 86.6% of patients who received the TriClip device saw a reduction in TR severity of at least one grade. In addition to a strong safety profile for the procedures in patients considered to be at high risk for surgery, a significant proportion of patients also saw an improvement in their heart failure symptoms as assessed using the New York Heart Association functional classification and Kansas City Cardiomyopathy Questionnaire score, noted the company.

Abbott noted that its transcatheter tricuspid valve repair system is an investigational device only. The TriClip valve repair system is built on the foundation of Abbott’s MitraClip system, which has been commercially available in the United States since 2013 and in Europe since 2008.