Abbott Launches Real-World TriClip Study

Abbott revealed that it’s begun the TREAT TR study, a post-market evaluation of its TriClip transcatheter edge-to-edge repair (TEER) device to treat tricuspid regurgitation (TR).

The study will enroll about 1,000 people at up to 100 sites in the U.S., Canada, and Europe, following them for five years with check-ins at discharge, 30 days, six months and one year, then once annually for the remaining four years. Some patients will be enrolled in a sub-study assessing TriClip to potentially reverse cardiac remodeling.

The first enrollment in the TREAT TR study took place at Hospital Clínic de Barcelona in Spain, led by Xavier Freixa, MD and his cardiac team.

TriClip’s TEER technology is delivered through a vein in the leg, avoiding open-heart surgery. The device clips together the tricuspid valve leaflets to restore blood flow. Most patients go home after an average one-day hospital stay.

The device has been evaluated in multiple studies, including the TRILUMINATE pivotal trial, which supported FDA approval after showing that the system safely reduced TR and heart failure hospitalizations while improving quality of life. Real-world data presented at the 2026 New York Valves conference, involving 3,035 patients across 278 U.S. sites, showed comparable reductions in TR and improvements in quality of life.

“Prior to TriClip’s availability, many patients with tricuspid regurgitation had few treatment options because medical therapy didn’t relieve their symptoms or they were at an increased risk for conventional open-heart surgery,” said Anita Asgar, MD, section head of interventional cardiology and medical director for the Bluhm Cardiovascular Institute, Structural Heart Program at Northwestern Medicine in Chicago, Ill. and co-principal investigator of the TREAT TR study. “Through multiple clinical studies and in working directly with patients, we’ve seen that TriClip can have a profound impact on the lives of people with TR, and we’re excited to see additional evidence to support this minimally invasive device.”

TriClip has been approved in more than 50 countries, including the U.S., Canada, and Europe, since receiving CE mark approval in 2020. More than 15,000 patients have been treated with the device, according to Abbott.