Clinical Trial

TRicuspid Uk STudy

Study acronym: TRUST
Not Yet Recruiting
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Summary
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-19.
Trial Details
NCT Number NCT07133386
Lead Sponsor Barts & The London NHS Trust
Collaborators: King's College Hospital NHS Trust, Oxford University Hospitals NHS Trust, Royal Brompton & Harefield NHS Foundation Trust
Conditions Tricuspid Regurgitation
Enrollment 150 participants
Start Date 2026-07-31
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-27