Status:
RECRUITING
Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
The optimal CA strategy for persistent AF remains unknown. Current data highlight the need for a better understanding of the substrate and mechanisms of arrhythmia maintenance in this population. Atri...
Eligibility Criteria
Inclusion
- 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
- 4\. Subjects must be able to provide informed consent.
Exclusion
- 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
Key Trial Info
Start Date :
August 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
502 Patients enrolled
Trial Details
Trial ID
NCT03347227
Start Date
August 24 2018
End Date
December 1 2024
Last Update
May 8 2024
Active Locations (15)
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1
Libin Cardiovascular Institute
Calgary, Alberta, Canada
2
Vancouver General Hospital
Vancouver, British Columbia, Canada
3
QEII Health Sciences Centre, Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 1V7
4
Hamilton General Hospital
Hamilton, Ontario, Canada