Status:
NOT_YET_RECRUITING
Randomized Controlled Trial- Ablation Strategy for Paroxysmal Atrial Fibrillation - Trigger and Substrate Guided Wide Area Radiofrequency Ablation Compared to Pulsed Field Ablation Pulmonary Vein Isolation
Lead Sponsor:
Ottawa Heart Institute Research Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Abbott
Conditions:
Atrial Fibrillation
Catheter Ablation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Atrial Fibrillation (AF) is a heart rhythm disturbance that affects over a million people in North America. AF can cause strokes, heart failure, poor quality of life and may lead to premature death. C...
Detailed Description
Catheter ablation (CA) for paroxysmal atrial fibrillation (AF) is beset by the significant limitation of recurrent AF in one third of subjects. Subjects with recurrence of AF usually require repeat ab...
Eligibility Criteria
Inclusion
- Age ≥18 years on the date of consent for the trial.
- Subjects must have Paroxysmal AF with at least two episodes of AF over the past 12 months; Early Persistent AF- at least two episodes of AF.
- At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans- telephonic monitor (TTM) or Loop Recorder.
- Subjects must be able to provide informed consent.
Exclusion
- Persistent and permanent AF
- History of previous catheter or surgical ablation for AF, AFl, AT, AVNRT, AVRT.
- Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial.
- Previous left atrial (LA) ablation or LA surgery.
- Previous pulmonary vein stenosis or pulmonary vein stent.
- Pre-existing hemi-diaphragmatic paralysis.
- Active intracardiac thrombus.
- Contraindication to systemic oral anticoagulation therapy or radiocontrast materials.
- Current immunosuppressant therapy (corticosteroids, biologic immunomodulators; such patients may be considered if they can safely discontinue immunosuppressants for three months prior to and for three months following catheter ablation).
- Reversible causes of AF (eg. uncontrolled hyperthyroidism, within six months of cardiac surgery).
- Left ventricular ejection fraction \<35%.
- NYHA Class 3-4 heart failure.
- Hypertrophic cardiomyopathy with septal or posterior LV wall thickness of \>1.8 cm.
- Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation).
- Known adverse reaction to adenosine.
- Significant chronic kidney disease (eGFR \<30ml/min/1.73m2).
- Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, subjects with patent foramen ovale will not be excluded).
- Pregnant subjects.
- Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial.
- Life expectancy less than one-year.
- Currently participating or anticipated to participate in clinical trials of drug, device or biologic agents that could affect the results of this trial.
- Unwilling or unable to comply fully with study procedures and follow-up.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
556 Patients enrolled
Trial Details
Trial ID
NCT04823299
Start Date
August 1 2025
End Date
February 1 2029
Last Update
August 19 2025
Active Locations (2)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
2
McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4