NCT07133386

TRicuspid Uk STudy

TRUST Trial Protocol

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Barts & The London NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	transcatheter edge to edge repair	Implantation of a tricuspid transcatheter edge to edge device
DEVICE	Placebo	placebo

Timeline

• Start date: 2026-07-31
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2025-08-21
• Last updated: 2026-02-27

Locations

1 site across 1 country: United Kingdom