Abbott has begun the TREAT TR study, to assess the safety and performance of its TriClip transcatheter edge-to-edge repair (TEER) system for patients with tricuspid regurgitation (TR), also referred to as a leaky tricuspid valve.
The prospective, post-market study aims to build on previously established clinical evidence for TriClip’s use, with the first participant enrolled at Hospital Clínic de Barcelona in Spain under the direction of lead investigator Xavier Freixa.
It will enrol around 1,000 participants at up to 100 sites across Canada, Europe, and the US. Participants will be monitored at discharge, 30 days, six months, and one year after the procedure, and then annually for up to five years.
A specific group of patients will be included in a sub-study to investigate if the TriClip system is associated with reversing cardiac remodelling, a process involving structural changes to the heart after injury or ongoing overload.
Northwestern Medicine Bluhm Cardiovascular Institute structural heart programme interventional cardiology section head and medical director Anita Asgar is serving as the co-principal investigator of TREAT TR.
Asgar said: “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.
“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’s TEER technology is delivered through a leg vein, avoiding open-heart surgery by clipping together the valve leaflets to help correct the leakage.
Existing studies such as the TRILUMINATE Pivotal trial have evaluated TriClip’s safety and efficacy, with findings supporting its approval by the US Food and Drug Administration (FDA).
Further data from a June 2026 study involving 3,035 patients in the US indicated results consistent with prior trials, highlighting significant reductions in TR severity and hospitalisation rates.
In April 2026, Abbott received FDA approval and CE Mark for its Ultreon 3.0 AI-powered coronary imaging platform.
