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Active Not RecruitingNCT05057507

Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
91 (actual)
Sponsor
University of Edinburgh · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTAtrial cardiac magnetic resonance imagingTo include assessment of atrial size, shape, function, fibrosis and fat
DIAGNOSTIC_TESTAtrial electro-anatomic mappingTo include assessment of atrial voltage and local activation time
OTHERAtrial fibrillation symptom questionnaireTo include assessment of atrial fibrillation symptoms and quality of life
DIAGNOSTIC_TESTPatch-based 2 week ambulatory monitorTo assess atrial fibrillation burden post-ablation

Timeline

Start date
2022-07-01
Primary completion
2024-10-15
Completion
2026-07-31
First posted
2021-09-27
Last updated
2026-04-17

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05057507. Inclusion in this directory is not an endorsement.