Clinical trial NCT05057507: Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
Official title: Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2021-09-27
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 115 patients undergoing electrophysiological assessment will be recruited with inclusion and exclusion criteria as indicated above.

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.

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.

Eligibility criteria: 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 written explanations given in English or German as appropriate.

Primary outcomes:
measure: Proportion of patients with each mechanism of atrial fibrillation defined by computational modelling
timeFrame: 4 years
Secondary outcomes:
measure: Atrial properties - atrial structural and functional properties will be compared between patients in each mechanistic atrial fibrillation group (as defined in Outcome 1)
timeFrame: 4 years
measure: 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)
timeFrame: 4 years
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Mark D O'Neill, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: NHS Lothian, Edinburgh
name: Neil Grubb, FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University Heart and Vascular Center, Hamburg
name: Andreas Rillig, MD
role: PRINCIPAL_INVESTIGATOR
References: