Atrial FibrillationReCETT-AFNCT05057507
Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University of Edinburgh at 2 sites in United Kingdom.
Trial summary
The aim of this research is to classify patients by the dominant mechanism of continuous atrial electrical activation during atrial fibrillation. This approach seeks to improve on existing classifications which are based solely on the duration of the arrhythmia (<7 days, >7 days and >1 year). This is a cohort study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Atrial cardiac magnetic resonance imaging, Atrial electro-anatomic mapping and Atrial fibrillation symptom questionnaire
- How many people
- 91 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Jan 2022to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Adult, Older adult
Study population: Up to 115 patients undergoing electrophysiological assessment will be recruited with inclusion and exclusion criteria as indicated above.
Who may be able to join
- Symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation diagnosed - within 24 months preceding the consent date.
- Planned radiofrequency ablation for atrial fibrillation consisting of pulmonary vein isolation.
- Able and willing to comply with study follow-up requirements
- Able and willing to provide written informed consent
Who cannot join
- Any clinical contra-indication to ablation
- Any disease limiting life expectancy to < 1year
- Contra-indication to MRI including renal dysfunction (eGFR<30ml/min)
- Potential participant currently pregnant or breast feeding
- Prior ablation, cardiac surgery or presence of any prosthetic valves
- Myocardial infarction or percutaneous coronary intervention within 3 months preceding consent date
Show all 13Show fewer
- Hypertrophic cardiomyopathy or other inherited cardiac condition
- Presence / likely implant of any pacemaker, cardiac resynchronization therapy device or implantable defibrillator within 1 year
- Enrolment in an existing interventional atrial fibrillation study which alters treatment or follow-up.
- Use of amiodarone for any indication within 6 months prior to the planned ablation procedure
- Use of any anti-arrhythmic drug for an arrhythmia indication other than atrial fibrillation
- Prior documented cavotricuspid isthmus dependent right atrial flutter and planned cavotricuspid isthmus ablation to be performed at the time of atrial fibrillation ablation
- Unable to understand verbal or written explanations given in English or German as appropriate.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
NHS Lothian
Edinburgh
Guy's and St Thomas' NHS Foundation Trust
London
About this study
The aim of this research is to classify patients by the dominant mechanism of continuous atrial electrical activation during atrial fibrillation. This approach seeks to improve on existing classifications which are based solely on the duration of the arrhythmia (<7 days, >7 days and >1 year). This is a cohort study. Patients undergoing clinically indicated electrophysiology study or AF ablation will have invasive assessment of cardiac electrophysiological profile at the time of their planned procedure, undergo 2-week ambulatory monitoring before and after the procedure, complete symptom questionnaires before and after their procedure and undergo atrial cardiac magnetic resonance imaging before their procedure.
Read the detailed description
Atrial fibrillation is a common condition causing an irregular heartbeat, breathlessness and tiredness. Atrial fibrillation occurs owing to abnormalities in the electrical circuits controlling the upper heart chambers. Atrial fibrillation can be treated with a keyhole procedure called ablation. During ablation small areas in the heart are burnt away to stop the abnormal circuits causing atrial fibrillation. Unfortunately, ablation only works for 50-90% of people. We are not sure why, but possibly because the electrical circuits responsible are different in every heart. This research will examine how these electrical circuits can be identified and treated. A new system using computer modelling will be developed to identify the electrical circuits present. In the future we hope this approach could be used to design tailor-made treatments for each patient. A combination of computer studies and studies involving patients will be used to test this new approach in this study. For this study patients who are already planned to undergo an ablation procedure will be recruited providing data for three Work Packages. Consent will be sought to access routine investigations and data for research purposes (e.g. ECGs, blood tests, ambulatory monitoring, cardiac imaging, and outpatient clinical assessment); and collect extra data for research including additional cardiac imaging, a 2-week heart monitor pre- and post-ablation, and extra electrical measurements made during the ablation procedure.
- Conditions
- Atrial Fibrillation
- Being tested
- Atrial cardiac magnetic resonance imaging, Atrial electro-anatomic mapping, Atrial fibrillation symptom questionnaire, Patch-based 2 week ambulatory monitor
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrial cardiac magnetic resonance imagingDiagnostic test
To include assessment of atrial size, shape, function, fibrosis and fat
Atrial electro-anatomic mappingDiagnostic test
To include assessment of atrial voltage and local activation time
Atrial fibrillation symptom questionnaireOther
To include assessment of atrial fibrillation symptoms and quality of life
Patch-based 2 week ambulatory monitorDiagnostic test
To assess atrial fibrillation burden post-ablation
| Study group | Role | What they receive |
|---|---|---|
| Atrial fibrillation patients undergoing radiofrequency catheter ablation | Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled. Receives: Diagnostic Test: Atrial cardiac magnetic resonance imaging; Diagnostic Test: Atrial electro-anatomic mapping; Other: Atrial fibrillation symptom questionnaire; Diagnostic Test: Patch-based 2 week ambulatory monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling
The primary outcome is the creation of patient specific computational models for the investigation of atrial fibrillation mechanisms in patients. Mechanisms of atrial fibrillation will be defined based on computational modelling results and each patient will be assigned to the dominant mechanism of atrial fibrillation present.
Measured: 4 years
Secondary outcomes (2)
Atrial properties - atrial structural and functional properties will be compared between patients in each mechanistic atrial fibrillation group (as defined in Outcome 1)
The secondary outcome (1) is to determine which atrial properties are associated with each mechanism of atrial fibrillation in patients. Atrial structural and functional properties will be measured using atrial magnetic resonance imaging and invasive atrial electrophysiology; and quantified as follows: Atrial structure - volume (ml), sphericity (%); fibrosis burden (%); pericardial fat volume (ml); Atrial function - conduction velocity (m/s); refractoriness (ms); atrial electrical area (cm).
Measured: 4 years
Treatment effects - burden of atrial fibrillation in patients classified as 'successfully treated' compared to those classified as 'not successfully treated' using the modelling framework (as defined in Outcome 1)
The secondary outcome (2) is to determine how atrial properties can be modified using currently-available therapies to improve treatment for atrial fibrillation. Computer simulations will be performed in which the critical atrial properties (as defined in Outcome 2) are modified and actual treatment response will be compared to predicted treatment response by (A) correlating actual atrial fibrillation burden (% time in atrial fibrillation) with predicted atrial fibrillation burden (% time in atrial fibrillation) and (B) calculating diagnostic accuracy metrics (sensitivity, specificity, C-statistic) for prediction of atrial fibrillation inducibility and recurrence following ablation.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start7 Jan 2022
- Primary completion7 Jan 2024
- Study completion31 Mar 2026
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.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Mark D O'Neill, FRCP, Principal investigator, Guy's and St Thomas' NHS Foundation TrustNeil Grubb, FRCP, Principal investigator, NHS Lothian, EdinburghAndreas Rillig, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057507
- Sponsor's protocol ID
- AC20151
- Acronym
- ReCETT-AF
- Status last verified
- Jun 2026
- First submitted
- 16 Sep 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05057507
- Acronym / sponsor ID
- ReCETT-AF / AC20151
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 7 Jan 2024 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 27 Sep 2021 (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.
The aim of this research is to classify patients by the dominant mechanism of continuous atrial electrical activation during atrial fibrillation. This approach seeks to improve on existing classifications which are based solely on the duration of the arrhythmia (<7 days, >7 days and >1 year). This is a cohort study. Patients undergoing clinically indicated electrophysiology study or AF ablation will have invasive assessment of cardiac electrophysiological profile at the time of their planned procedure, undergo 2-week ambulatory monitoring before and after the procedure, complete symptom questionnaires before and after their procedure and undergo atrial cardiac magnetic resonance imaging before their procedure.
Detailed description
Atrial fibrillation is a common condition causing an irregular heartbeat, breathlessness and tiredness. Atrial fibrillation occurs owing to abnormalities in the electrical circuits controlling the upper heart chambers. Atrial fibrillation can be treated with a keyhole procedure called ablation. During ablation small areas in the heart are burnt away to stop the abnormal circuits causing atrial fibrillation. Unfortunately, ablation only works for 50-90% of people. We are not sure why, but possibly because the electrical circuits responsible are different in every heart. This research will examine how these electrical circuits can be identified and treated. A new system using computer modelling will be developed to identify the electrical circuits present. In the future we hope this approach could be used to design tailor-made treatments for each patient. A combination of computer studies and studies involving patients will be used to test this new approach in this study. For this study patients who are already planned to undergo an ablation procedure will be recruited providing data for three Work Packages. Consent will be sought to access routine investigations and data for research purposes (e.g. ECGs, blood tests, ambulatory monitoring, cardiac imaging, and outpatient clinical assessment); and collect extra data for research including additional cardiac imaging, a 2-week heart monitor pre- and post-ablation, and extra electrical measurements made during the ablation procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial fibrillation patients undergoing radiofrequency catheter ablation | – | Diagnostic Test: Atrial cardiac magnetic resonance imaging, Diagnostic Test: Atrial electro-anatomic mapping, Other: Atrial fibrillation symptom questionnaire, Diagnostic Test: Patch-based 2 week ambulatory monitorUp to 115 patients undergoing radiofrequency catheter ablation will be enrolled. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Up to 115 patients undergoing electrophysiological assessment will be recruited with inclusion and exclusion criteria as indicated above.
Key inclusion criteria (4 listed)
- Symptomatic paroxysmal atrial fibrillation or persistent atrial fibrillation diagnosed - within 24 months preceding the consent date.
- Planned radiofrequency ablation for atrial fibrillation consisting of pulmonary vein isolation.
- Able and willing to comply with study follow-up requirements
- Able and willing to provide written informed consent
Key exclusion criteria (13 listed)
- Any clinical contra-indication to ablation
- Any disease limiting life expectancy to < 1year
- Contra-indication to MRI including renal dysfunction (eGFR<30ml/min)
- Potential participant currently pregnant or breast feeding
- Prior ablation, cardiac surgery or presence of any prosthetic valves
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 |
|---|---|---|
| Atrial cardiac magnetic resonance imagingTo include assessment of atrial size, shape, function, fibrosis and fat | Diagnostic test | Atrial fibrillation patients undergoing radiofrequency catheter ablation |
| Atrial electro-anatomic mappingTo include assessment of atrial voltage and local activation time | Diagnostic test | Atrial fibrillation patients undergoing radiofrequency catheter ablation |
| Atrial fibrillation symptom questionnaireTo include assessment of atrial fibrillation symptoms and quality of life | Other | Atrial fibrillation patients undergoing radiofrequency catheter ablation |
| Patch-based 2 week ambulatory monitorTo assess atrial fibrillation burden post-ablation | Diagnostic test | Atrial fibrillation patients undergoing radiofrequency catheter ablation |
Primary outcome
Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling
Time frame: 4 years
The primary outcome is the creation of patient specific computational models for the investigation of atrial fibrillation mechanisms in patients. Mechanisms of atrial fibrillation will be defined based on computational modelling results and each patient will be assigned to the dominant mechanism of atrial fibrillation present.
2 secondary outcomes
Atrial properties - atrial structural and functional properties will be compared between patients in each mechanistic atrial fibrillation group (as defined in Outcome 1)
Time frame: 4 years
Treatment effects - burden of atrial fibrillation in patients classified as 'successfully treated' compared to those classified as 'not successfully treated' using the modelling framework (as defined in Outcome 1)
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mark D O'Neill, FRCP principal investigator
Guy's and St Thomas' NHS Foundation Trust
Neil Grubb, FRCP principal investigator
NHS Lothian, Edinburgh
Andreas Rillig, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
2 sites 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, run by University of Edinburgh at 2 sites 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling (time frame: 4 years). 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 5 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.