Actively 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
Led by Ottawa Heart Institute Research Corporation · Updated on 2026-04-29
556
Participants Needed
2
Research Sites
205 weeks
Total Duration
On this page
Sponsors
O
Ottawa Heart Institute Research Corporation
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Atrial fibrillation (AF) is a common heart rhythm disorder affecting over a million people in North America and is associated with serious complications including stroke, heart failure, reduced quality of life, and premature death. Catheter ablation has been shown to be more effective than medications for controlling symptoms and reducing the risk of these complications; however, recurrence of AF after ablation remains a significant challenge, often due to incomplete or ineffective initial procedures. This clinical trial aims to determine whether a novel, patient-tailored ablation strategy can improve outcomes compared to the current standard-of-care approach. Participants will be randomly assigned to undergo either standard pulmonary vein isolation or a more individualized ablation procedure that identifies and targets patient-specific sources of AF. All participants will undergo the ablation procedure, receive continuous heart rhythm monitoring, and be followed over time to assess recurrence and safety outcomes.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Diagnosed with paroxysmal atrial fibrillation with at least one documented episode in the past 12 months (patients on antiarrhythmic medications are exempt)
- Ability to provide informed consent
You will not qualify if you...
- Persistent or permanent atrial fibrillation
- Prior catheter or surgical ablation for AF, atrial flutter, atrial tachycardia, AVNRT, or AVRT
- Documented AVNRT, AVRT, atrial tachycardia, or atrial flutter before enrollment
- Previous left atrial ablation or surgery
- History of pulmonary vein stenosis or pulmonary vein stent
- Pre-existing hemi-diaphragmatic paralysis
- Active intracardiac thrombus
- Contraindication to systemic oral anticoagulation
- Current immunosuppressant therapy unless stopped 3 months before and after ablation
- Reversible causes of AF such as uncontrolled hyperthyroidism or recent cardiac surgery
- Left ventricular ejection fraction below 35%
- NYHA Class 4 heart failure
- Hypertrophic cardiomyopathy
- Significant moderate or severe valve disease
- Mechanical mitral prosthetic valves
- Known adverse reaction to adenosine
- Chronic kidney disease stage 4 or higher
- Significant congenital heart disease except patent foramen ovale
- Pregnancy
- Stroke or transient ischemic attack within 6 months prior to consent
- Thromboembolic events within 6 months before enrollment
- Participation in other interventional trials affecting results
- Primary pulmonary hypertension
- Rheumatic heart disease
- Thrombocytosis, thrombocytopenia, or other hypercoagulable states
- Active systemic infection
- Life expectancy less than 12 months
- Inability or unwillingness to comply with study procedures and follow-up
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
2
McGill University Health Center
Montreal, Quebec, Canada, H3G 1A4
Not Yet Recruiting
Research Team
G
Girish Nair, MD
CONTACT
S
Sonya Jancar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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