Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation

NCT ID: NCT05057507

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-03-06

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrial fibrillation patients undergoing radiofrequency catheter ablation

Up to 115 patients undergoing radiofrequency catheter ablation will be enrolled.

Atrial cardiac magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

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

Atrial electro-anatomic mapping

Intervention Type DIAGNOSTIC_TEST

To include assessment of atrial voltage and local activation time

Atrial fibrillation symptom questionnaire

Intervention Type OTHER

To include assessment of atrial fibrillation symptoms and quality of life

Patch-based 2 week ambulatory monitor

Intervention Type DIAGNOSTIC_TEST

To assess atrial fibrillation burden post-ablation

Interventions

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Atrial cardiac magnetic resonance imaging

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

Intervention Type DIAGNOSTIC_TEST

Atrial electro-anatomic mapping

To include assessment of atrial voltage and local activation time

Intervention Type DIAGNOSTIC_TEST

Atrial fibrillation symptom questionnaire

To include assessment of atrial fibrillation symptoms and quality of life

Intervention Type OTHER

Patch-based 2 week ambulatory monitor

To assess atrial fibrillation burden post-ablation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark D O'Neill, FRCP

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Neil Grubb, FRCP

Role: PRINCIPAL_INVESTIGATOR

NHS Lothian, Edinburgh

Andreas Rillig, MD

Role: PRINCIPAL_INVESTIGATOR

University Heart and Vascular Center, Hamburg

Locations

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NHS Lothian

Edinburgh, , United Kingdom

Site Status

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AC20151

Identifier Type: -

Identifier Source: org_study_id

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