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RECRUITING

NCT04823299

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

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

556

Start Date

2026-03-23

Completion Date

2030-03

Last Updated

2026-04-29

Healthy Volunteers

Conditions

Atrial Fibrillation Catheter Ablation Radiofrequency Catheter Ablation

Interventions

PROCEDURE

PVI-ONLY, CONTROL ARM

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

PROCEDURE

PVI-PLUS ARM, INTERVENTIONAL ARM

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

Inclusion Criteria: 1. Age ≥18 years on the date of consent for the trial. 2. 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. 3. Subjects must be able to provide informed consent. Exclusion Criteria: 1. Persistent and permanent AF. 2. History of previous catheter or surgical ablation for AF, AFl, AT, Atrioventricular Nodal Reentrant Tachycardia (AVNRT), Atrioventricular Reentrant Tachycardia (AVRT). 3. Documented AVNRT, AVRT, AT or Atrial Flutter prior to enrolment in the trial. 4. Previous left atrial (LA) ablation or LA surgery. 5. Previous pulmonary vein stenosis or pulmonary vein stent. 6. Pre-existing hemi-diaphragmatic paralysis. 7. Active intracardiac thrombus. 8. Contraindication to systemic oral anticoagulation therapy 9. 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). 10. Reversible causes of AF (e.g., uncontrolled hyperthyroidism, within six months of cardiac surgery). 11. Left ventricular ejection fraction \<35%. 12. NYHA Class 4 heart failure. 13. Hypertrophic cardiomyopathy 14. Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation). 15. Patients with mechanical mitral prosthetic valves 16. Known adverse reaction to adenosine. 17. Chronic Kidney Disease ≥ Stage 4. 18. Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, subjects with patent foramen ovale will not be excluded). 19. Pregnant subjects. 20. Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial. 21. History of thromboembolic events in the 6 months preceding enrollment. 22. Currently participating or anticipated to participate in interventional clinical trials of drug, device or biologic agents that could affect the results of this trial. 23. Primary pulmonary hypertension 24. Rheumatic heart disease 25. Thrombocytosis, thrombocytopenia and other hypercoagulable states 26. Active systemic infection 27. Patients with life expectancy less than 12 months. 28. Unwilling or unable to comply fully with study procedures and follow-up.

Locations (2)

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

McGill University Health Center

Montreal, Quebec, Canada