Abbott (NYSE:ABT) said today that it’s launching another study of its TriClip tricuspid valve repair device, this time aimed at winning U.S. regulatory approval.
The five-year, 700-patient Triluminate pivotal trial, under an investigational device exemption from the FDA, is the first such study of a transcatheter, non-surgical treatment for patients with severe tricuspid regurgitation, Abbott said. The TriClip device is based on Abbott’s Mitraclip mitral valve repair product.
The TriClip pivotal is designed to compare the device with standard medical treatment and includes a single arm of patients with more complex tricuspid disease. The primary endpoint is a composite of all-cause mortality or tricuspid repair surgeries, heart failure hospitalizations and quality-of-life at 12 months. Secondary outcomes include change in tricuspid regurgitation grade from severe to moderate or less and freedom of major adverse events at 30 days, plus changes in QOL score and six-minute walk test at 12 months. The primary completion date is set for August 2022, with final results in March 2027, according to ClinicalTrials.gov.
Abbott said TriClip is undergoing parallel review with the FDA and the Centers for Medicare & Medicaid Services for a national reimbursement decision.
“Patients with symptomatic tricuspid regurgitation are often at an increased risk for conventional surgery. As a result, many are not referred for intervention,” co-primary investigator Dr. David Adams, of New York City’s Mount Sinai Health System, said in prepared remarks. “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.”
“While we’ve made substantial progress on a number of fronts for challenging structural heart conditions, tricuspid regurgitation impacts far too many patients worldwide, and physicians are limited by a lack of meaningful therapy alternatives to surgery,” added structural heart CMO Dr. Neil Moat. “Early results with our TriClip repair system have been encouraging and we’re excited to continue driving innovation that we believe will benefit more patients in the future.”
Another 85-patient study by the same name, launched in 2017, is slated to back Abbott’s bid for CE Mark approval in the European Union. Earlier this year Abbott released 30-day data showing a reduction in tricuspid regurgitation symptoms, with some 86.6% of patients undergoing at least a one-grade reduction in severity.
