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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 heart rhythm disturbance that affects over a million people in North America. AF can cause strokes, heart failure, poor quality of life and may lead to premature death. Catheter ablation has been shown to be superior to medications for symptoms, prevention of stroke and heart failure. AF recurrence is a problem after catheter ablation. Our research has found that in most cases AF recurrence occurs because the catheter procedure was ineffective. The objective of our clinical trial is to find out if a new method of performing the catheter procedure will be more effective in preventing AF recurrence compared to the current standard of care ablation procedure. Subjects will be randomly allocated to undergo either the standard of care ablation, or the novel patient tailored ablation. The novel method aims to understand the unique factors responsible for AF in each individual and uses this information to perform a patient-tailored catheter ablation procedure. This is expected to improve the results of AF ablation. The effectiveness and safety of the ablation procedure will be specifically evaluated in women to understand the effect of sex on AF ablation.

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

2025-08

Completion Date

2029-02

Last Updated

2025-08-19

Healthy Volunteers

Conditions

Atrial Fibrillation Catheter Ablation Radiofrequency Catheter Ablation

Interventions

PROCEDURE

Cryoballoon ablation

Cryoballoon pulmonary vein isolation ablation

PROCEDURE

Radiofrequency catheter ablation +EPS guided trigger and substrate ablation

RF based WACA ± electrophysiological testing guided ablation of non-PV triggers of AF and low voltage area ablation

Inclusion Criteria: 1. Age ≥18 years on the date of consent for the trial. 2. Subjects must have Paroxysmal AF with at least two episodes of AF over the past 12 months; Early Persistent AF- at least two episodes of AF. 3. At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans- telephonic monitor (TTM) or Loop Recorder. 4. 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, AVNRT, 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 or radiocontrast materials. 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 (eg. uncontrolled hyperthyroidism, within six months of cardiac surgery). 11. Left ventricular ejection fraction \<35%. 12. NYHA Class 3-4 heart failure. 13. Hypertrophic cardiomyopathy with septal or posterior LV wall thickness of \>1.8 cm. 14. Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation). 15. Known adverse reaction to adenosine. 16. Significant chronic kidney disease (eGFR \<30ml/min/1.73m2). 17. Significant congenital heart disease (including atrial septal defects or pulmonary vein abnormalities; however, subjects with patent foramen ovale will not be excluded). 18. Pregnant subjects. 19. Cerebral ischemic event (stroke or transient ischemic attack) in the six months prior to consenting for the trial. 20. Life expectancy less than one-year. 21. Currently participating or anticipated to participate in clinical trials of drug, device or biologic agents that could affect the results of this trial. 22. 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