Abbott has initiated TREAT TR, a prospective post-market study of the TriClip transcatheter edge-to-edge repair system for tricuspid regurgitation. The first patient was enrolled in Barcelona under lead investigator Xavier Freixa, and the trial plans to recruit about 1,000 patients across Canada, Europe and the US with follow-up through five years. A sub-study will examine whether TriClip can reverse cardiac remodelling. Anita Asgar is co-principal investigator.
Abbott Launches TREAT TR Study to Evaluate TriClip for Tricuspid Regurgitation
TriClip’s TEER technology is delivered through a leg vein
Abbott has launched the prospective, post-market TREAT TR study to evaluate the safety and performance of its TriClip transcatheter edge-to-edge repair (TEER) system for patients with tricuspid regurgitation (TR), commonly described as a leaky tricuspid valve.
The first participant was enrolled at Hospital Clínic de Barcelona in Spain under lead investigator Xavier Freixa. The study aims to recruit about 1,000 patients at as many as 100 sites across Canada, Europe and the United States, with follow-up visits at discharge, 30 days, six months and one year, then annually for up to five years to monitor safety and device performance.
A dedicated sub-study will follow a specific cohort to determine whether TriClip is associated with reversal of cardiac remodelling — the structural changes the heart undergoes after injury or sustained pressure or volume overload.
Study Leadership
Anita Asgar, head of the structural heart programme in the interventional cardiology section and medical director at Northwestern Medicine Bluhm Cardiovascular Institute, is serving as co-principal investigator for TREAT TR.
“Before TriClip was available, many patients with tricuspid regurgitation had limited treatment options because medical therapy did not relieve symptoms or they faced higher risk with conventional open-heart surgery. Through clinical studies and direct patient care, we have seen TriClip meaningfully improve quality of life, and we look forward to further evidence supporting this minimally invasive option.”
About the Device and Evidence
The TriClip TEER system is delivered via femoral vein access and works by grasping and clipping the tricuspid valve leaflets together to reduce regurgitation while avoiding open-heart surgery. Prior research, including the TRILUMINATE Pivotal trial, evaluated TriClip’s safety and efficacy and supported its regulatory approval in the US.
Additional real-world data published in June 2026 from a US study of 3,035 patients reported results consistent with earlier trials, showing meaningful reductions in TR severity and lower hospitalization rates.
Separately, in April 2026 Abbott received FDA approval and CE Mark clearance for its Ultreon 3.0 AI-powered coronary imaging platform.
What This Means
TREAT TR will expand the body of evidence on TriClip in a large, geographically diverse population and investigate longer-term outcomes, including potential reverse remodelling of the right heart. The results could influence treatment options for patients with TR who are at elevated risk for conventional surgery.
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