RecruitingNot ApplicableNCT04823299

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

AWARE-2 - 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


Sponsor

Ottawa Heart Institute Research Corporation

Enrollment

556 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called PVI-ONLY, CONTROL ARM and a procedure called PVI-PLUS ARM, INTERVENTIONAL ARM for people with atrial fibrillation, catheter ablation, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPVI-ONLY, CONTROL ARM

PULSED FIELD ABLATION (PFA) PVI-ONLY STRATEGY: CONTROL ARM

PROCEDUREPVI-PLUS ARM, INTERVENTIONAL ARM

RADIOFREQUENCY CATHETER ABLATION (RFA) PVI-PLUS : INTERVENTION ARM


Locations(2)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada

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NCT04823299


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