TRicuspid Uk STudy (TRUST)

February 26, 2026 updated by: Barts & The London NHS Trust

TRUST Trial Protocol

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom
        • St Bartholomew's Hospital
        • Contact:
        • Principal Investigator:
          • Kush Patel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged >18 years at recruitment
  • Severe or more symptomatic TR determined by transthoracic echocardiography
  • Optimized medical and/or device therapy for a minimum of 30 days
  • Medications, including diuretics should be stable over the past 30 days
  • Baseline KCCQ 75 or less on minimum 2 assessments at least 2 weeks apart
  • New York Heart Association (NYHA) Functional Class II or ambulatory class IV
  • Morphology of tricuspid valve suitable for TEER with expectation of a reduction of severity of TR to moderate or less
  • Willing to provide written informed consent

Exclusion Criteria:

  • Presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results or result in an expected life expectancy of less than 12 months
  • Active malignancy associated with a prognosis of <1 year
  • Left ventricular ejection fraction (LVEF)<20%

  • Tricuspid valve leaflet anatomy which may preclude TriClip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:

    • Evidence of calcification in the grasping area
    • Presence of a severe coaptation defect (>10mm) of the tricuspid leaflets. - Severe leaflet defect(s) preventing proper device placement
    • Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.
  • Tricuspid valve anatomy not evaluable by transthoracic (TTE) or transoesophageal echo (TOE)
  • Rheumatic heart disease affecting the tricuspid valve
  • Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction. Note: Patients with concomitant mitral and tricuspid valve disease will have the option of having any significant mitral regurgitation managed, then waiting 60 days prior to being reassessed for the current trial.
  • Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the TriClip.
  • Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 3.0 cm2 and/or mean gradient ≥3 mmHg as measured by the transthoracic echocardiography
  • Pregnant
  • Unable to comply with study protocol
  • Uncontrolled systemic hypertension with a systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg
  • Severe pulmonary hypertension (sPAP>70mmHg) or fixed pre-capillary pulmonary hypertension assessed by cardiac catheterization
  • Stroke within prior 90 days
  • Chronic dialysis
  • Bleeding disorders or hypercoagulable state
  • Active peptic ulcer or active gastrointestinal (GI) bleeding
  • Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enrol 30 days after discontinuation of antibiotics with no active infection).
  • Known allergy or hypersensitivity to device materials
  • Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
  • Enrolment in another clinical trial that involves treatment of tricuspid regurgitation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T-TEER arm
Interventional device delivered via the transferral venous route to improve computation of the tricuspid valve leaflets with the aim of reducing tricuspid regurgitation.
Device: transcatheter edge to edge repair
Implantation of a tricuspid transcatheter edge to edge device
Placebo Comparator: Placebo
no therapeutic intervention undertaken. Patient will have all the same steps as the TriClip arm without actually having the TriClip device or delivery system inserted into the body.
Device: Placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kansas City Cardiomyopathy Questionnaire
Time Frame: every 2 weeks twice before the intervention and for 3 months post-intervention
health status questionnaire
every 2 weeks twice before the intervention and for 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

King's College Hospital NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 31, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 19, 2025

First Submitted That Met QC Criteria

August 19, 2025

First Posted (Actual)

August 21, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 338776

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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