The TRICURE FIH study results and future trials update

Background/Introduction Despite increasing attention to the management of tricuspid regurgitation (TR), a substantial unmet clinical need persists for safe and effective transcatheter therapies in high-risk patients with severe TR. A novel transcatheter tricuspid valve replacement (TTVR) system has been specifically developed for the tricuspid position. Its innovative dual-stent design allows accommodation of a wide range of anatomical configurations while preserving optimal valve geometry and functional performance. Purpose The objective of this First-in-Human study is to assess the safety and feasibility of the TTVR system in patients with clinically significant tricuspid regurgitation. Methods This prospective, multicentre, single-arm, nonrandomized First-in-Human clinical investigation is conducted across eight sites in France, Belgium, and Switzerland. A total of 20 adult patients with severe, symptomatic tricuspid regurgitation who were considered unsuitable for open-heart surgery were enrolled. The primary safety endpoint is a composite endpoint measure that includes all-cause mortality, rehospitalization for heart failure, and reintervention for failed tricuspid intervention at 30 days. The primary performance endpoint is device success, defined as reduction of tricuspid regurgitation by at least 1 grade between the baseline and post-intervention evaluation (as assessed by the echo core laboratory), and no more than moderate tricuspid regurgitation. The study is closely monitored by an independent Data Safety Monitoring Committee (DMC) and an independent Clinical Events Committee (CEC), which adjudicates all adverse events. Additionally, all echocardiographic and computed tomography (CT) imaging are evaluated by independent core laboratories to ensure objective and consistent data assessment. Results In the TRICURE FIH a total of 20 patients (mean age 77 ± 6.6 years, 90 % female, TRI-SCORE 4.6 ± 2.5) were enrolled. All patients were symptomatic with NYHA ≥ II and had severe (grade ≥ 3) TR at baseline. The procedure time was 35 ± 16 minutes. At 30 days, the primary safety endpoint, a composite of major adverse events, was observed in 7 patients (35 %), including three all-cause deaths, three re-interventions (thereof two elective), and one hospitalization for heart failure. The primary performance endpoint was successfully achieved in all patients (100%), with all patients having a TR reduction of at least 3 grades, and none of the patients having more than mild TR post-procedure. No device-related pacemaker implant was reported. Conclusion(s) The primary endpoint results of the TRICURE FIH study provide convincing evidence of the feasibility and safety of this novel TTVR system. Additional outcomes will be assessed in the ongoing TRICURE EU PIVOTAL study.