At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Echocardiogram (diagnostic test)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Echocardiogram — diagnostic test: Ultrasound scan of the heart
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 60
- Started
- 2023-08-23
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation
- • Clinical study - 60 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with atrial fibrillation
Where?
- • London - St Bartholomew's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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: * Baseline echocardiography * Cpex Echocardiography * Blood test: BNP * 1 year follow up Echocardiography Participants will be stratified into three subgroups: * Atrial Functional MR * Atrial Functional TR * Mixed MR \& TR
More detail
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 * Identify \& characterise phenotypes in functional mitral and tricuspid valve regurgitation * Identify risk factors for progression of disease and outcome. 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 * Progression of valve disease defined as worsening of mitral or tricuspid regurgitation \> 1 grade at 1 year. * Functional: New York Heart Association Class, Predicted VO2max (\<84%). * Heart Failure admission within 1 year of recruitment. * Mortality. Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓agreement to take part
- ✓Age of 18 years or older
- ✓Atrial fibrillation
- ✓Moderate or severe atrial valve disease
- ✓Adequate 2D echocardiography views including parasternal long axis, short axis, apical two chamber, apical three...
Who cannot take part
- ✗Unwilling or unable to give consent
- ✗Left ventricular impairment (ejection fraction \< 50%).
- ✗Primary/organic valve disease
See the full criteria
Where Is This Study? (1 UK site)
St Bartholomew's Hospital
London, United Kingdom
How to Get in Touch
Jawza Aldakhil
Sponsor contactCONTACT