Clinical Trial

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

Study acronym: AWARE-2
Recruiting
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Summary
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2021-03-26; most recent amendment 2026-04-23.
Status change: Not Yet Recruiting → Recruiting 2026-04-23
Trial Details
NCT Number NCT04823299
Lead Sponsor Ottawa Heart Institute Research Corporation
Collaborators: Canadian Institutes of Health Research (CIHR), Abbott
Conditions Atrial Fibrillation, Catheter Ablation, Radiofrequency Catheter Ablation
Enrollment 556 participants
Start Date 2026-03-23
Primary Completion 2029-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-29