About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Subjects must be able to provide informed consent.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
PVI-ONLY, CONTROL ARM
Procedure/SurgeryPULSED FIELD ABLATION (PFA) PVI-ONLY STRATEGY: CONTROL ARM
PVI-PLUS ARM, INTERVENTIONAL ARM
Procedure/SurgeryRADIOFREQUENCY CATHETER ABLATION (RFA) PVI-PLUS : INTERVENTION ARM
Treatment groups
Trial outcomes
Primary outcomes
Freedom from atrial fibrillation, atrial flutter or atrial tachycardia
AF, AFl or AT, symptomatic or asymptomatic lasting ≥ 30 seconds
Secondary outcomes
Atrial fibrillation burden
Total duration of AF recorded on ambulatory monitoring/total duration of monitoring
Long-term rate of documented atrial fibrillation, atrial flutter or atrial tachycardia
Long-term rate of documented AF, AFl or AT lasting ≥ 30 seconds
Incidence of any ECG/ILR documented atrial fibrillation, atrial flutter or atrial tachycardia
Incidence of any ECG/ILR documented AF, AFl or AT (symptomatic or asymptomatic; lasting ≥ 30 seconds
Ablation procedure duration
Catheter ablation procedure time
Sponsors and contacts
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Ottawa Heart Institute Research Corporation
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Abbott
Collaborator