Valvular & structural heart disease
TRICURE: first-in-human study of the Topaz transcatheter tricuspid heart valve system
Authors' conclusion
The TRICURE FIH study provides evidence of the feasibility and safety of a novel TTVR system.
Study context
- Population
- Patients with tricuspid regurgitation (TR) at high risk for surgery
- Participants
- 20 patients
- Outcome
- Safety: composite of all-cause mortality, HF rehospitalisation and reintervention for failed tricuspid therapy; performance: device success (TR reduction ≥1 grade with no more than moderate TR post-procedure)
- Follow-up
- 30 days
Methodological detailsprospective, multicentre, single-arm, Follow-up extending to 5 years
- Prospective
- Multicentre
- Single-arm
- Follow-up extending to 5 years
Main finding
As reported in the abstract
Primary safety endpoint (composite of all-cause mortality, HF rehospitalisation, reintervention for failed tricuspid therapy) and primary performance endpoint (device success)
Primary safety endpoint (composite of major adverse events)
35%
Primary performance endpoint (device success) achieved in all patients
100%
Observational data: associations, not effects.
Further findings
Procedure time (delivery system insertion to removal)
- Procedure time, minutes
- 35±16
TR reduction · 30 days
- Patients with more than mild TR post-procedure
- 0
- All patients had TR reduction of at least 3 grades
RV reverse remodelling (exemplary case report) · 6 months
- Complete elimination of TR and RV reverse remodelling in one case
- 19%
- Single case report
Safety
- No device-related pacemaker implant reported
Original publication
TRICURE: first-in-human study of the Topaz transcatheter tricuspid heart valve system. EuroIntervention. Published 14 November 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →