TCT 2025: TRILUMINATE Pivotal Trial Confirms Safety, Efficacy and Quality-of-Life (QoL) Gains with TriClip Transcatheter Edge-to-Edge Repair (T- TEER) for Tricuspid Regurgitation (TR)
This news is covered by the Medical Dialogues Bureau present at the TCT Conference 2025, being held in San Francisco, USA.
TriClip transcatheter edge-to-edge repair (T-TEER) demonstrated high procedural success, significant reduction in tricuspid regurgitation (TR), and marked improvement in quality of life at 30 days, based on new analyses from the TRILUMINATE Pivotal trial. The updated findings were presented by Dr. Jonathan G. Schwartz and colleagues at TCT 2025.
The TRILUMINATE Pivotal trial is the largest study of transcatheter tricuspid repair to date. It includes a randomized arm comparing TriClip therapy with guideline-directed medical therapy (GDMT) and a single-arm cohort. Following completion of the randomized phase, a continued access study (CAS) was initiated, providing the basis for this 30-day analysis, which included all 847 patients with an attempted TriClip implant.
TriClip therapy, designed to reduce regurgitation by approximating tricuspid valve leaflets, was performed successfully in 98.7% of patients. The average number of clips implanted was two, and 82% of cases utilized the latest TriClip G4 device. The median hospital stay was one day, and more than 96% of patients were discharged home.
At 30 days, the reduction in TR severity was striking. Overall, 95% of patients experienced at least a one-grade reduction in TR, with 77% achieving a two-grade or greater reduction. Quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), improved by an average of 17 points (p<0.0001).
Clinical outcomes were favorable, with low rates of adverse events through 30 days. All-cause mortality was 0.5%, heart failure hospitalization occurred in 3.0%, and stroke was reported in only 0.2% of patients. Major bleeding was observed in 3%, and tricuspid valve reintervention was required in just 0.6%. Single-leaflet device attachment occurred in 6.7%, but without device embolization or thrombosis.
Notably, TriClip was also safe and effective in patients with transvalvular cardiac implantable electronic device (CIED) leads. Among 175 such patients, TR reduction and improvements in KCCQ scores were comparable to the overall cohort, with a 19-point average gain in KCCQ and an 84% achievement of moderate or less TR at 30 days. Major bleeding was 3%, and tricuspid valve reintervention occurred in only 1%.
Operator experience correlated with improved efficiency and outcomes. Centers with greater procedural experience demonstrated shorter procedure times, fewer ICU admissions, and slightly lower rates of adverse events, while maintaining similar effectiveness in TR reduction.
In summary, the TRILUMINATE Pivotal trial’s continued access data confirm that TriClip therapy provides a safe, effective, and reproducible transcatheter treatment for severe tricuspid regurgitation. With low complication rates, rapid recovery, and significant improvements in symptoms and quality of life, TriClip continues to expand its role as a standard-of-care option for patients with symptomatic TR at prohibitive surgical risk.
Reference: Jonathan G. Schwartz et al., Lessons learned from 800+ patients treated with tricuspid TEER - The TRILUMINATE Pivotal trial, TCT Conference 2025, San Francisco.
https://www.tctconference.com/
