Valvular & structural heart diseaseRandomised controlled trial
Tricuspid Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation
- Randomised controlled trial
- international
- adaptive trial design
- Enrolled August 21, 2019, to June 29, 2022
Authors' conclusion
TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in 6-minute walk distance and health status. Rates of all-cause mortality or tricuspid valve surgery and HFH through 1 year were not reduced by T-TEER.
Study context
- Population
- Patients with symptomatic, severe tricuspid regurgitation (TR)primary cohort n = 350
- Participants
- 572 patients
- Comparison
- Tricuspid transcatheter edge-to-edge repair (T-TEER) vs control
- Primary endpoint
- Hierarchical composite of:
- All-cause mortality or tricuspid valve surgery
- HF hospitalisations
- KCCQ quality-of-life improvement
- Follow-up
- 1 year
Primary result
As reported in the abstract
- All-cause mortality or tricuspid valve surgery
- HFH
- KCCQ quality-of-life improvement
Freedom from all-cause mortality and tricuspid valve surgery through 12 months
≥15-point KCCQ improvement
events/patient-year
| Outcome | Device | Control |
|---|---|---|
| Annualized HFH rate | 0.17 | 0.20 |
- Primary endpoint met for the full cohort, win ratio
- 1.84
Secondary outcomes
Moderate or less TR · 30 days
- T-TEER vs control
- 88.9% vs 5.3%
- P < 0.0001
Kansas City Cardiomyopathy Questionnaire (KCCQ) change · 1 year
- T-TEER vs control (points)
- 13.0 ± 1.4 points vs −0.5 ± 1.4 points
- P < 0.0001
6-minute walk distance change · 1 year
- T-TEER vs control
- 1.7 ± 7.5 m vs −27.4 ± 7.4 m
- P < 0.0001
Safety
Freedom from major adverse events
- Freedom from major adverse events with T-TEER
- 98.9%
- vs performance goal: 90%
- P < 0.0001
Original publication
Summarised from the published abstract; every number is checked against it