TRicuspid Uk STudy
ConditionTricuspid Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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%
Evidence of calcification in the grasping area
Trial design
Treatments tested in this trial
- transcatheter edge to edge repair
- Placebo
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Barts & The London NHS Trust
Lead sponsor
King's College Hospital NHS Trust
Collaborator
Oxford University Hospitals NHS Trust
Collaborator
Royal Brompton & Harefield NHS Foundation Trust
Collaborator
Source ClinicalTrials.gov