Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation
NCT ID: NCT05057507
Last Updated: 2025-12-04
Study Results
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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ACTIVE_NOT_RECRUITING
91 participants
OBSERVATIONAL
2022-07-01
2026-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
To include assessment of atrial size, shape, function, fibrosis and fat
Atrial electro-anatomic mapping
To include assessment of atrial voltage and local activation time
Atrial fibrillation symptom questionnaire
To include assessment of atrial fibrillation symptoms and quality of life
Patch-based 2 week ambulatory monitor
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
Atrial electro-anatomic mapping
To include assessment of atrial voltage and local activation time
Atrial fibrillation symptom questionnaire
To include assessment of atrial fibrillation symptoms and quality of life
Patch-based 2 week ambulatory monitor
To assess atrial fibrillation burden post-ablation
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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King's College London
OTHER
University of Edinburgh
OTHER
Responsible Party
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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
Guy's and St Thomas' NHS Foundation Trust
London, , United Kingdom
Countries
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Other Identifiers
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AC20151
Identifier Type: -
Identifier Source: org_study_id
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