Valvular & structural heart diseaseCohort study
Transcatheter Edge-to-Edge Repair in Patients With Complex Tricuspid Valve Anatomy
- Single-arm cohort of the TRILUMINATE Pivotal trial
- multicenter
- international
- performance goal
Authors' conclusion
In patients with complex tricuspid anatomies, TEER with the TriClip system demonstrated excellent procedural safety with significant TR reduction and associated improvements in quality of life at 1 year.
Study context
- Population
- Patients with severe tricuspid regurgitation (TR) and complex tricuspid valve anatomy (excluded from the randomized arm)primary analysis population
- Participants
- 100 patients
- Outcome
- Survival with KCCQ score improvement ≥10 points
- Follow-up
- 1 year
Main finding
As reported in the abstract
1-year survival with KCCQ score improvement ≥10 points
Primary endpoint met (outcome)
46.2%
Performance goal
30%
P value vs performance goal
P = 0.0008
Observational data: associations, not effects.
Further findings
Moderate or less TR · 1 year
- Subjects with moderate or less TR
- 81%
All-cause mortality and HF hospitalization · 1 year
- All-cause mortality
- 15%
- HF hospitalization
- 24%
NYHA functional class and KCCQ overall scores · 1 year
- Significant improvements, maintained at 1 year
Safety
Major adverse events or deaths · 30 days postprocedure
- No major adverse events or deaths
Original publication
Transcatheter Edge-to-Edge Repair in Patients With Complex Tricuspid Valve Anatomy. JACC Cardiovasc Interv. Published 9 December 2024. doi:10.1016/j.jcin.2024.08.035
Summarised from the published abstract; every number is checked against it