Abbott kicks off a clinical investigation to capture outcomes from real-world use of TriClip in patients with a malfunctioning tricuspid heart valve

Abbott has recently set in motion the TREAT TR study, a post-approval investigation of its pioneering TriClip transcatheter edge-to-edge repair system, an instrument built expressly to address tricuspid regurgitation, the condition in which the tricuspid valve fails to seal correctly and allows blood to leak backwards. The investigation will examine how the device fares outside of controlled trial conditions and contribute new layers of evidence to an already established record of patient benefit. Enrollment opened at Hospital Clínic de Barcelona in Spain, where Xavier Freixa, M.D., and his cardiac team led the way with the first patient.

Roughly 1,000 participants will be recruited across as many as 100 institutions spanning the United States, Canada, and Europe. Each individual will remain under observation for five years, with clinical touchpoints at discharge, the 30-day mark, six months, the one-year anniversary, and each year thereafter. A dedicated sub-cohort will take part in an additional arm of the investigation, exploring whether TriClip can prompt a reversal of cardiac remodelling, the architectural shifts the heart undergoes in response to injury or prolonged mechanical strain.

“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, M.D., Section Head of Interventional Cardiology and Medical Director for the Bluhm Cardiovascular Institute Structural Heart Program at Northwestern Medicine in Chicago, 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.”

The tricuspid valve sits at the gateway between the right atrium and the right ventricle, regulating the passage of blood between them. When the valve leaflets fail to meet properly, blood reverses course, pushing the heart to compensate through extra effort and giving rise to symptoms such as exhaustion and laboured breathing. Left unaddressed, the condition can spiral into atrial fibrillation, progressive heart failure, and eventually death. For those whose symptoms persist despite pharmacological management and who carry too great a risk for conventional surgery, TriClip offers a viable path toward a better quality of life.

Rather than requiring an open surgical approach, TriClip reaches the tricuspid valve via a catheter threaded through a leg vein. Once in position, the device clamps the valve’s leaflets together, correcting the leak and allowing blood to flow as it should. The vast majority of recipients need only a single overnight hospital stay before heading home to recover.

Evidence for TriClip has accumulated through a succession of investigations, with the TRILUMINATE Pivotal trial serving as a cornerstone, demonstrating that the system reliably reduces tricuspid regurgitation, lowers the rate of heart failure hospitalisations, and delivers measurable quality of life gains. Those findings provided the foundation for its US Food and Drug Administration clearance.

Further corroboration arrived in June 2026 at the New York Valves conference, where a registry-based analysis covering 3,035 patients treated at 278 sites across the United States mirrored the outcomes seen in the pivotal trial, with participants recording substantial reductions in tricuspid regurgitation and meaningful improvements in how they felt day to day.

“Clinical studies have continued to reinforce the benefits of repairing the tricuspid valve with TriClip and the significant improvements that it brings to people’s daily lives, including reducing the rate of hospitalizations due to heart failure,” said Lars Sondergaard, M.D., Chief Medical Officer of Abbott’s structural heart business. “We believe the TREAT TR study will further confirm TriClip’s exceptional safety profile and effectiveness in reducing tricuspid regurgitation across a diverse range of patients and locations.”

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Abbott, TriClip, tricuspid heart valve