TRI-FR Trial Results Demonstrate T-TEER Lowers HF Hospitalizations at 2 Years

March 30, 2026—Transcatheter tricuspid edge-to-edge repair (T-TEER) combined with guideline-directed medical therapy reduced adverse clinical outcomes at 2 years compared with medical therapy alone in patients with severe, symptomatic tricuspid regurgitation, according to results from the TRI-FR trial presented at the American College of Cardiology’s Annual Scientific Session (ACC.26).

According to the ACC press release, the findings are notable because the randomized study did not permit crossover from the control arm to device therapy, allowing investigators to assess longer-term outcomes without treatment contamination. This design distinguishes TRI-FR from prior T-TEER trials and may provide clearer estimates of treatment effect.

At 2 years, the primary composite endpoint occurred in 19.7% of patients treated with T-TEER plus medical therapy compared with 34.5% of those assigned to medical therapy alone. Hospitalization for worsening heart failure (HF) occurred in 13.8% versus 23%, respectively, corresponding to a 40% relative reduction in risk. The composite endpoint included changes in HF severity, patient-reported health status, and major adverse cardiovascular events, defined as death, myocardial infarction, stroke, HF hospitalization, or urgent revascularization.

“We have shown that transcatheter T-TEER combined with standard-of-care medical therapy significantly reduces the long-term need for hospitalization for recurrent HF at 2 years, compared with standard-of-care medical therapy alone,” said Principal Investigator Erwan Donal, MD, PhD, with 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,” Dr. Donal continued. “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.”

As noted in the press release, TRI-FR enrolled 300 patients (mean age, 78 years; 63.7% women) across 24 centers in France and Belgium. The population had advanced disease, with 91% classified as having very severe tricuspid regurgitation and a similar proportion with atrial fibrillation. Approximately 40% had been hospitalized for HF in the year before enrollment.

Unlike other randomized studies, patients assigned to the control group were not allowed to cross over to T-TEER, in part due to lack of reimbursement for the TriClip device (Abbott) within the French national health system during the study period. Investigators reported that both groups were followed prospectively according to the prespecified protocol.

Investigators plan extended follow-up to 5 years to assess survival and are evaluating cost implications of adding T-TEER to medical therapy. The study was unblinded, which investigators identified as a limitation.

The study was funded by the French Ministry of Health, with additional support from Abbott Vascular, the manufacturer of the TriClip device.