TRICURE: first-in-human study of the Topaz transcatheter tricuspid heart valve system

Abstract

Background: Given the poor prognosis of tricuspid regurgitation (TR) patients, there is growing interest in addressing TR, particularly since the emergence of novel transcatheter tricuspid valve interventions for patients at high risk for surgery.

Aims: The TRICURE first-in-human (FIH) study evaluates the initial feasibility and clinical safety of the Topaz transcatheter tricuspid valve replacement (TTVR) system in treating TR. Featuring a novel dual-stent design, the system is specifically engineered for the unique anatomy of the tricuspid valve. It has a flexible outer stent with low radial force designed to accommodate annular dynamics and conform to the non-circular, variable shapes of the tricuspid valve, coupled to a rigid inner stent aiming to maintain valve function integrity.

Methods: TRICURE FIH is a prospective, multicentre, first-in-human study with follow-up extending to 5 years. The primary safety endpoint is a composite measure including all-cause mortality, heart failure rehospitalisation, and reintervention for failed tricuspid therapy at 30 days. The primary performance endpoint is device success, defined as a TR reduction ≥1 grade with no more than moderate TR post-procedure.

Results: A total of 20 patients were enrolled. The procedure time (from delivery system insertion to removal) was 35±16 minutes. At 30 days, the primary safety endpoint, a composite of major adverse events, was observed in 35%, and 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. An exemplary case report demonstrates complete elimination of TR and a reverse remodelling of the right ventricle of 19% at 6 months.

Conclusions: The TRICURE FIH study provides evidence of the feasibility and safety of a novel TTVR system. Outcomes need to be confirmed in a larger series. (ClinicalTrials.gov: NCT05126030)