An observational study in Atrial Fibrillation, Functional Mitral Regurgitation and Functional Tricuspid Regurgitation, sponsored by Barts & The London NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Barts & The London NHS Trust · Observational
A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation.
Participant will under go:
Participants will be stratified into three subgroups:
Rationale
The natural history and risk factors for atrial valve disease are poorly understood and characterised. This study will examine differences between atrial mitral and atrial tricuspid disease and help us understand the natural history of these pathologies.
Study objectives
Primary objective
Secondary objective
Compare the three groups: atrial functional MR, atrial functional TR, and mixed disease, and identify any differences/similarities.
Primary endpoint
Effective Regurgitant Orifice Area at 1 year
Secondary endpoint
Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 60 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Barts & The London NHS Trust is the lead sponsor of 151 studies on the registry; 21 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ultrasound scan of the heart
Effective Regurgitant Orifice Area at 1 year
Measure the EROA by echocardiography after 1 year
Time frame: 1 year
Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.
Measure the change in regurgitation severity
Time frame: 1 year
Functional: New York Heart Association Class, Predicted VO2max (<84%).
Evaluate participants' physical abilities and endurance, focusing on two key measures: The New York Heart Association (NYHA) Functional Classification and the predicted maximum oxygen uptake (VO2max)
Time frame: 1 year
Heart Failure admission within 1 year of recruitment.
incidence of heart failure admissions within a one-year period following the recruitment of participants.
Time frame: 1 year
Mortality
Document and analyze the mortality rates among participants
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Aug 2027, 48 months after the start.
Of 550 non-industry observational studies under Atrial Fibrillation, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 91. This study's planned 48 months is close to that.
Counting every sponsor, half of 698 studies reached it within 38 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Barts & The London NHS Trust →