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
| NCT ID | NCT04823299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 556 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 556 participants in total. It began in 2026-03-23 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Girish Nair, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT04823299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04823299 currently recruiting?
Yes, NCT04823299 is actively recruiting participants. Contact the research team at GNair@ottawaheart.ca for enrollment information.
Where is the NCT04823299 trial being conducted?
This trial is being conducted at Ottawa, Canada, Montreal, Canada.
Who is sponsoring the NCT04823299 clinical trial?
NCT04823299 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Girish Nair, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 556 participants.
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