TRIC-I-HF
TRICuspid Intervention in Heart Failure trial (TRIC-I-HF-DZHK24)
Patient / Population Intervention / Exposure Comparison Outcome
In 360 patients with severe tricuspid regurgitation and right heart failure, transcatheter tricuspid intervention was compared with medical therapy alone on death, heart-failure hospitalisation and quality of life at 12 months.
N
360
Design
investigator-initiated, prospective, multicentre (29 German sites), open-label, randomised strategy trial; 2:1 transcatheter tricuspid valve intervention plus OMT vs OMT alone; hierarchical primary endpoints at 12 months; total follow-up 3 years
Endpoint
first primary: hierarchical composite of all-cause mortality, heart failure hospitalisation and quality-of-life improvement at 12 months (win ratio); second primary (tested if first positive): time to all-cause death or heart failure hospitalisation