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

Atrial Fibrillation Catheter Ablation Radiofrequency Catheter Ablation

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

Inclusion Criteria4

Age ≥18 years on the date of consent for the trial.
Subjects must have paroxysmal AF with at least one episode of AF over the past 12 months (patients on antiarrhythmic medications do not need to satisfy this criterion).
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 Criteria28

Persistent and permanent AF.
History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant Tachycardia (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
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 (e.g., uncontrolled hyperthyroidism, within six months of cardiac surgery).
Left ventricular ejection fraction <35%.
NYHA Class 4 heart failure.
Hypertrophic cardiomyopathy
Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation).
Patients with mechanical mitral prosthetic valves
Known adverse reaction to adenosine.
Chronic Kidney Disease ≥ Stage 4.
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.
History of thromboembolic events in the 6 months preceding enrollment.
Currently participating or anticipated to participate in interventional clinical trials of drug, device or biologic agents that could affect the results of this trial.
Primary pulmonary hypertension
Rheumatic heart disease
Thrombocytosis, thrombocytopenia and other hypercoagulable states
Active systemic infection
Patients with life expectancy less than 12 months.
Unwilling or unable to comply fully with study procedures and follow-up.