Recruiting

Ablation Strategy

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT04823299

Conditions

Atrial Fibrillation

Catheter Ablation

Radiofrequency Catheter Ablation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PVI-ONLY, CONTROL ARM

PVI-PLUS ARM, INTERVENTIONAL ARM

Study Details

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.

Conditions

Atrial Fibrillation

Catheter Ablation

Radiofrequency Catheter Ablation

Study ID

NCT04823299

Start date

Mar 23, 2026

Status verified date

Aug, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

556 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PVI-ONLY ablation

Pulsed Field Ablation (PFA), control arm

experimental: PVI-PLUS ablation

RADIOFREQUENCY CATHETER ABLATION (RFA), interventional arm

Interventions

PVI-ONLY, CONTROL ARM

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

PVI-PLUS ARM, INTERVENTIONAL ARM

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

Primary outcome measure

  • Freedom from atrial fibrillation, atrial flutter or atrial tachycardia [ Time Frame: 61 to 730 days after ablation ]

Central Contacts and Locations

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

Girish Nair, MD

GNair@ottawaheart.ca

Principal Investigator:

Girish Nair, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-09-03.