This is a multicentre, randomised, placebo-controlled trial conducted at St Bartholomew's Hospital, John Radcliff Hospital, Royal Brompton Hospital, and Kings College London Hospital. The aim is to evaluate the benefits in health status from transcatheter edge to edge repair with the TriClip device in patients with severe or more symptomatic tricuspid regurgitation. A total of 150 patients will be recruited in a 1:1 ratio for TriClip or placebo. The primary endpoint of this study (change in Kansas City Cardiomyopathy Questionnaire between the treatment and placebo arm) will be analysed using a linear mixed model and compared between patients who receive the TriClip versus those who have a placebo procedure. Study duration: 3 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Implantation of a tricuspid transcatheter edge to edge device
placebo
St Bartholomew's Hospital
London, United Kingdom
Kansas City Cardiomyopathy Questionnaire
health status questionnaire
Time frame: every 2 weeks twice before the intervention and for 3 months post-intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.