Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
ReCETT-AF
1 other identifier
observational
91
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2021
CompletedFirst Posted
Study publicly available on registry
September 27, 2021
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
ExpectedApril 17, 2026
April 1, 2026
2.3 years
September 16, 2021
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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)
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)
4 years
Study Arms (1)
Atrial fibrillation patients undergoing radiofrequency catheter ablation
Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled.
Interventions
To include assessment of atrial size, shape, function, fibrosis and fat
To include assessment of atrial voltage and local activation time
To include assessment of atrial fibrillation symptoms and quality of life
To assess atrial fibrillation burden post-ablation
Eligibility Criteria
Up to 115 patients undergoing electrophysiological assessment will be recruited with inclusion and exclusion criteria as indicated above.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- King's College Londoncollaborator
Study Sites (2)
NHS Lothian
Edinburgh, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D O'Neill, FRCP
Guy's and St Thomas' NHS Foundation Trust
- PRINCIPAL INVESTIGATOR
Neil Grubb, FRCP
NHS Lothian, Edinburgh
- PRINCIPAL INVESTIGATOR
Andreas Rillig, MD
University Heart and Vascular Center, Hamburg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2021
First Posted
September 27, 2021
Study Start
July 1, 2022
Primary Completion
October 15, 2024
Study Completion (Estimated)
July 31, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share