TRicuspid Uk STudy

Official title

TRUST Trial Protocol

Overview

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

Interventions

• Device transcatheter edge to edge repair
  Implantation of a tricuspid transcatheter edge to edge device
• Device Placebo
  placebo

Primary outcome measures

• Kansas City Cardiomyopathy Questionnaire [Time frame: every 2 weeks twice before the intervention and for 3 months post-intervention]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• St Bartholomew's Hospital — London

Identifiers

NCT: NCT07133386 · 338776

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗