Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibri… (NCT05057507) | Clinical Trial Compass
CompletedNot Applicable
Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
United Kingdom91 participantsStarted 2022-01-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 writt…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used computational modelling to identify the specific mechanism driving each patient's atrial fibrillation — has that kind of personalised mapping approach made its way into standard care yet, or is it still only available through research settings?
2Since this trial has already completed and was measuring how often different AF mechanisms were identified by the computer models, has any published data come out yet that my doctor thinks is relevant to my own type of atrial fibrillation?
3The trial wasn't testing a drug or procedure directly — it was building and validating a simulation tool — so how might results from this kind of study eventually change the way my ablation or other AF treatment would be planned?
4Because this was a non-interventional, modelling-focused study rather than a treatment trial, are there any follow-on trials now recruiting that actually use these computational models to guide therapy, and would my doctor recommend I look into those?
5Given that this trial categorised patients by their AF mechanism using computer simulations, does my doctor think knowing my specific AF mechanism would change the treatment options they'd recommend for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling