Skip to main content
OpenTrials
Completed

NCT Number: NCT05057507

Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NHS Lothian, Edinburgh, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atrial cardiac magnetic resonance imaging

Diagnostic Test

To include assessment of atrial size, shape, function, fibrosis and fat

Atrial electro-anatomic mapping

Diagnostic Test

To include assessment of atrial voltage and local activation time

Atrial fibrillation symptom questionnaire

Other

To include assessment of atrial fibrillation symptoms and quality of life

Patch-based 2 week ambulatory monitor

Diagnostic Test

To assess atrial fibrillation burden post-ablation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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).

  2. 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

    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.

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • King's College London

Registry information

Acronym: ReCETT-AF

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Sep 27, 2021
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.