RecruitingNot ApplicableNCT03347227
Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation
Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation (Coast-AF) Randomized Clinical Trial
Sponsor
Ottawa Heart Institute Research Corporation
Enrollment
502 participants
Start Date
Aug 24, 2018
Study Type
INTERVENTIONAL
Conditions
Summary
A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Age ≥18 years ;
- Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF
- At least one episode of AF that is sustained beyond 3 months in duration ; documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study;
- Modified DR-FLASH score \>=4
- \. Subjects must be able to provide informed consent.
Exclusion Criteria9
- History of previous catheter ablation for AF or left atrial flutter;
- History of previous surgical ablation for AF;
- Known intracardiac thrombus;
- Contraindication to systemic oral anticoagulation therapy;
- Reversible causes of AF;
- Hypertrophic cardiomyopathy;
- Severe valvular disease (mitral/aortic stenosis or regurgitation);
- Subjects that are pregnant or breastfeeding;
- Comorbid condition with life expectancy \< 1 year
Interventions
PROCEDURECatheter ablation
Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT03347227
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