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
Qualifiers
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
Treatments tested in this trial
- PVI-ONLY, CONTROL ARM
- PVI-PLUS ARM, INTERVENTIONAL ARM
Treatment groups
Sponsors and collaborators
Ottawa Heart Institute Research Corporation
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Abbott
Collaborator