TRILUMINATE Study Evaluates Abbott's Tricuspid Valve Repair System
May 21, 2019—Abbott announced data from its TRILUMINATE study of the company's minimally invasive tricuspid valve repair system. The results were presented in a late-breaking trial session at EuroPCR, which is held May 21–24 in Paris, France.
According to the company, results at 30 days demonstrated that the investigational device is associated with a reduction of tricuspid regurgitation symptoms, suggesting a possible treatment option for people with this difficult-to-manage structural heart disease. Abbott's transcatheter tricuspid valve repair system builds on the company's clip-based MitraClip technology for the treatment of leaky mitral valves.
TRILUMINATE is a prospective, single-arm, multicenter study at 21 sites in Europe and the United States evaluating the safety and performance of the tricuspid valve repair system in 85 patients with symptomatic moderate or greater tricuspid regurgitation who were determined to be good candidates for percutaneous transcatheter intervention.
Abbott reported that the 30-day results demonstrated that 86.6% of patients saw a reduction in tricuspid regurgitation severity of at least one grade (P < .0001). There was a significantly greater proportion of patients categorized as New York Heart Association (NYHA) class I or II (80.5% at 30 days, compared with 25.6% at baseline), an improvement that was statistically significant. Additionally, patients also experienced a mean improvement in Kansas City Cardiomyopathy Questionnaire score from 53.05 at baseline to 67.25 at 30 days, which was an increase of 14.20 points (a five-point increase is considered clinically significant).
Clinical follow-up will continue through 6 months and at 1, 2, and 3 years. Abbott's transcatheter tricuspid valve repair system is an investigational device only, advised the company.
The study's lead investigator Georg Nickenig, MD, commented in the company's announcement, "Treating a leaky tricuspid heart valve has long presented a significant challenge for cardiologists because it is an extremely complex and difficult heart valve to treat. These data are extremely encouraging, and I am excited about the potential of transcatheter tricuspid valve repair as a minimally invasive treatment option for these very ill patients who have no other options."