TRicuspid Uk STudy

Launched by BARTS & THE LONDON NHS TRUST · Aug 19, 2025

Keywords

ClinConnect Summary

This clinical trial, called the TRicuspid UK Study, is looking at a new treatment for people with a heart problem called severe tricuspid regurgitation, where one of the heart valves doesn’t close properly and causes blood to flow backward. The study will test a device called the TriClip, which is designed to repair this valve using a minimally invasive procedure, meaning it doesn’t require open-heart surgery. Researchers want to see if using the TriClip helps improve patients’ health and quality of life compared to a placebo procedure, which acts as a control for comparison.

The trial plans to include about 150 adults who have severe symptoms from their tricuspid valve problem and who have already tried standard treatments like medications without enough improvement. To join, participants need to be over 18 years old and have a specific level of heart symptoms confirmed by heart scans. Those with certain other health problems or valve conditions won’t be eligible. If you take part, you’ll be randomly assigned to either receive the TriClip procedure or a placebo procedure, and your health will be monitored over three years to see how you do. This study is not yet recruiting, but it will take place at several hospitals in the UK, and your doctor will explain all the details if you’re eligible and interested.

Gender

ALL

Eligibility criteria

• 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