Abbott has begun its first randomized, pivotal trial to test a new method of fixing leaky tricuspid heart valves, where there are currently no approved minimally invasive repair therapies available.
The medtech giant’s TriClip system is based on its successful catheter-based MitraClip device—which pinches together the two leaflets of the heart’s bicuspid mitral valve, helping it to seal with every beat and prevent the backflow of mitral regurgitation.
By comparison, the tricuspid valve typically has three, more fragile leaflets to separate the heart’s right ventricle and atrium. If it does not fully close, tricuspid regurgitation can increase the volume and blood pressure in the heart as well as in the venous system, with severe cases contributing to heart failure and swelling in the limbs.
And though the MitraClip, one of Abbott’s best-performing products, has been used off-label in tricuspid repair procedures, the company is opting to develop a separately approved device.
Abbott’s randomized clinical study aims to enroll 700 patients with severe regurgitation despite previous treatments, to gauge the rate of subsequent heart failure hospitalizations while assessing quality of life and all-cause mortality out to five years. It is expected to read out preliminary data in August 2022.
The company estimates that about one in 30 people over age 65 have moderate to severe tricuspid regurgitation, though there are no approved non-surgical treatments.
"Patients with symptomatic tricuspid regurgitation are often at an increased risk for conventional surgery. As a result, many are not referred for intervention," study co-primary investigator David Adams, chairman of the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai said in a statement.
"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," Adams said.
A previous, single-arm study showed that the TriClip device was able to reduce the severity of regurgitation in 86.6% of 85 patients by at least one grade after 30 days. The data was presented during a late-breaking session at EuroPCR 2019.
"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," said Neil Moat, chief medical officer of Abbott's structural heart business. "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."