TRicuspid Uk STudy

NCT07133386 | Not Yet Recruiting DMC

• 1 other identifier: 338776
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Kansas City Cardiomyopathy Questionnaire

  health status questionnaire

  every 2 weeks twice before the intervention and for 3 months post-intervention

Study Arms (2)

T-TEER arm

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DEVICE

placebo

Placebo

transcatheter edge to edge repair DEVICE

Implantation of a tricuspid transcatheter edge to edge device

T-TEER arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• King's College Hospital NHS Trust: collaborator
• Barts & The London NHS Trust: lead

Study Sites (1)

St Bartholomew's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Kush Patel

CONTACT

+44 0207 3777 000; kush.patel1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, blinded, placebo-controlled randomised clinical trial

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 21, 2025
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

GB (1)