Atrial FibrillationNCT05920824
Atrial Functional Mitral Regurgitation and Tricuspid Regurgitation
An observational study of Atrial Fibrillation and Functional Mitral Regurgitation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Functional Mitral Regurgitation, Functional Tricuspid Regurgitation
- What is being tested?
- Echocardiogram
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Aug 2023to Aug 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital
Who may be able to join
- Informed consent
- 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 chamber and four chamber.
Who cannot join
- Unwilling or unable to give consent
- Left ventricular impairment (ejection fraction < 50%).
- Primary/organic valve disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital
London
Jawza Aldakhil, jawza.aldakhil@nhs.net
About this study
Official title: Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
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
Read the detailed description
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
- Being tested
- Echocardiogram
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramDiagnostic test
Ultrasound scan of the heart
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Regurgitant Orifice Area at 1 year
Measure the EROA by echocardiography after 1 year
Measured: 1 year
Secondary outcomes (4)
Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.
Measure the change in regurgitation severity
Measured: 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)
Measured: 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.
Measured: 1 year
Mortality
Document and analyze the mortality rates among participants
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start23 Aug 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjeev bhattacharyya, Principal investigator, Barts & The London NHS TrustJawza Aldakhil, Study chair, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920824
- Sponsor's protocol ID
- 326447
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
- ClinicalTrials.gov ID
- NCT05920824
- Acronym / sponsor ID
- 326447
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will take place from the out-patient clinics \& echocardiography laboratory at St Bartholomew's Hospital
Key inclusion criteria (5 listed)
- Informed consent
- 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 chamber and four chamber.
Key exclusion criteria (3 listed)
- Unwilling or unable to give consent
- Left ventricular impairment (ejection fraction < 50%).
- Primary/organic valve disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiogramUltrasound scan of the heart | Diagnostic test | – |
Primary outcome
Effective Regurgitant Orifice Area at 1 year
Time frame: 1 year
Measure the EROA by echocardiography after 1 year
4 secondary outcomes
Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.
Time frame: 1 year
Functional: New York Heart Association Class, Predicted VO2max (<84%).
Time frame: 1 year
Heart Failure admission within 1 year of recruitment.
Time frame: 1 year
Mortality
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjeev bhattacharyya principal investigator
Barts & The London NHS Trust
Jawza Aldakhil study chair
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Functional Mitral Regurgitation, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jawza Aldakhil (00447899770693, Jawza@outlook.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Regurgitant Orifice Area at 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.