Valvular & structural heart diseaseRandomised controlled trial
Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation
- Randomised controlled trial
- investigator-initiated
- prospective
- 1:1 randomisation
- 24 centres in France and Belgium
- March 2021 to March 2023; latest follow-up April 2024
Authors' conclusion
T-TEER reduces tricuspid regurgitation severity and improves a composite score driven by improved patient-reported outcome measures in patients with severe, symptomatic tricuspid regurgitation.
Study context
- Population
- Adults with severe, symptomatic tricuspid regurgitation
- Participants
- 300 adults
- Comparison
- Tricuspid transcatheter edge-to-edge repair (T-TEER) + optimized medical therapy (OMT) vs OMT alone
- T-TEER + OMTn = 152
- OMT alonen = 148reference
- Primary endpoint
- Composite clinical end point:
- Change in NYHA class
- Change in patient global assessment
- Major CV events
- Follow-up
- 1 year
Primary result
As reported in the abstract
Improved composite score
Secondary outcomes
Massive or torrential TR · 1 year
Mean
| Outcome | T-TEER + OMT | OMT alone |
|---|---|---|
| Overall KCCQ summary score · 1 year | 69.9 (SD 25.5) | 55.4 (SD 28.8) |
- Massive or torrential TR: P < .001
- Overall Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score: P < .001
Composite secondary outcome (all-cause death, tricuspid valve surgery, KCCQ score improvement or time to HF hospitalization)
- Win ratio
- 2.06 (95% CI, 1.38-3.08) (P < .001)
Original publication
Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation. JAMA. Published 14 January 2025. doi:10.1001/jama.2024.21189
Summarised from the published abstract; every number is checked against it