At two years of follow-up, patients with a poorly functioning tricuspid valve in the heart who received optimal medical therapy plus a minimally invasive procedure using a clip to repair the valve were significantly less likely to die, have a heart attack or stroke and 40% less likely to be hospitalized for heart failure compared with similar patients who were randomly assigned to optimal medical therapy alone. The study was presented at the American College of Cardiology’s Annual Scientific Session (ACC.26).
“We have shown that transcatheter tricuspid edge-to-edge repair (T-TEER) combined with standard-of-care medical therapy significantly reduces the long-term need for hospitalization for recurrent heart failure at two years, compared with standard-of-care medical therapy alone,” said principal investigator Erwan Donal, MD, PhD, professor at Rennes University Hospital in France.
“These findings are strengthened by the fact that, in contrast to prior randomized studies of T-TEER, no patients assigned to the control group crossed over to receive T-TEER during the follow-up period,” he said. “Without the confounding effect of crossover, it is clear that, among patients with very severe tricuspid regurgitation, T-TEER improved not only quality of life but also patients’ long-term outcomes.”
The tricuspid valve, one of four valves in the heart, controls blood flow from the right atrium (the heart’s upper-right chamber) to the right ventricle (the lower-right chamber). More common in women than men, tricuspid regurgitation occurs when the valve leaks, allowing blood to flow back into the right atrium. When this happens, the heart must work harder to pump blood effectively. Patients with severe tricuspid regurgitation frequently have symptoms such as severe fatigue and shortness of breath, an enlarged liver, kidney failure, and fluid accumulation in the abdomen, legs, ankles or feet.
Currently, the best available medical therapy for tricuspid regurgitation is diuretic medications that reduce fluid buildup in the body but often do not directly treat the leakage of blood through the valve, Donal said. However, T-TEER is a minimally invasive procedure in which a catheter (a long flexible tube) is used to place one or more tiny clips on the tricuspid valve leaflets to prevent blood from leaking back into the right atrium. The TRI-FR trial was designed to compare outcomes for patients with severe, symptomatic tricuspid regurgitation who were randomly assigned to treatment with either T-TEER plus standard-of-care medical therapy (T-TEER group) or standard-of-care medical therapy alone (control group).
The trial enrolled 300 patients (average age 78 years, 63.7% women) at 24 centers in France and Belgium. Ninety-one percent of the patients had extremely severe tricuspid regurgitation, 91% had atrial fibrillation (a rapid, irregular heartbeat) and about 70% had high blood pressure despite treatment with high doses of blood pressure medication. Patients also had shortness of breath and could not walk a quarter of a mile on a flat surface in under six minutes. Forty percent had been hospitalized for heart failure in the year before they enrolled in the trial.
The trial’s primary endpoint was a composite of change in heart failure severity; change in the patient’s self-reported health status; and a major adverse cardiovascular event (a fatal or non-fatal heart attack or stroke, hospitalization for worsening heart failure or the need for an emergency procedure to restore blood flow to the heart) at one year. Secondary outcomes included tricuspid regurgitation severity and a physician assessment of improvement in quality of life.
Unlike prior randomized trials of T-TEER, the design of the TRI-FR trial did not allow patients assigned to the control group to cross over to receive T-TEER during follow-up due to the French national health insurance system not reimbursing for the TriClip T-TEER device used in the trial. As a result, patients in both randomized groups continued to be followed prospectively, as prespecified in the study protocol, allowing the investigators to report long-term clinical outcomes beyond two years without treatment crossover, Donal said.
“These findings provide complementary evidence to trials such as TRILUMINATE conducted in the United States, where crossover was permitted,” he said. “To our knowledge, TRI-FR is therefore the first randomized study of T-TEER to report clinical outcomes beyond two years without crossover between treatment groups.”
At two years of follow-up, 19.7% of patients in the T-TEER group had experienced a primary endpoint event, compared with 34.5% in the control group. In the T-TEER group 13.8% of patients were hospitalized for worsening heart failure, compared with 23% in the control group, a 40% reduction in risk.
As a next step, Donal and his colleagues are analyzing whether treatment with T-TEER plus optimal medical therapy generates cost savings compared with optimal medical therapy alone. They also plan to follow the patients for a total of five years to evaluate whether patients who were treated with T-TEER live longer than those who did not.
A limitation of the study is that it was unblinded, meaning that both patients and their clinicians knew who had received T-TEER and who had not, Donal said.
The study was funded by the French Ministry of Health, with an additional grant from Abbott Vascular, maker of the TriClip device.
Donal will present the study, “Two-year Outcomes After Transcatheter Tricuspid Repair Without Cross-over in the Randomized Tri.Fr Trial,” on Sunday, March 29, at 4:00 p.m. CT / 21:00 UTC in the Main Tent, Great Hall.
ACC.26 will take place March 28-30, 2026, in New Orleans, bringing together cardiologists and cardiovascular specialists from around the world to share the newest discoveries in treatment and prevention. Follow @ACCinTouch, @ACCMediaCenter and #ACC26 for the latest news from the meeting.
The American College of Cardiology (ACC) is the global leader in transforming cardiovascular care and improving heart health for all. As the preeminent source of professional medical education for the entire cardiovascular care team since 1949, ACC credentials cardiovascular professionals in over 140 countries who meet stringent qualifications and leads in the formation of health policy, standards and guidelines. Through its world-renowned family of JACC Journals, NCDR registries, ACC Accreditation Services, global network of Member Sections, CardioSmart.org patient resources and more, the College is committed to ensuring a world where science, knowledge and innovation optimize patient care and outcomes. Learn more at ACC.org.
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