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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Heart Institute Research Corporation

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 volunteers

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

Design model

Parallel

Treatments tested in this trial

  • PVI-ONLY, CONTROL ARM

    Procedure/Surgery

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

  • PVI-PLUS ARM, INTERVENTIONAL ARM

    Procedure/Surgery

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

Treatment groups

556 Participants
are divided into 2 treatment groups
Group A: PVI-ONLY ablationActive comparator 1 intervention
Group B: PVI-PLUS ablationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Freedom from atrial fibrillation, atrial flutter or atrial tachycardia

AF, AFl or AT, symptomatic or asymptomatic lasting ≥ 30 seconds

Time frame
61 to 730 days after ablation

Secondary outcomes

1

Atrial fibrillation burden

Total duration of AF recorded on ambulatory monitoring/total duration of monitoring

Time frame
730 days
2

Long-term rate of documented atrial fibrillation, atrial flutter or atrial tachycardia

Long-term rate of documented AF, AFl or AT lasting ≥ 30 seconds

Time frame
730 days
3

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

Time frame
First 60 days after catheter ablation
4

Ablation procedure duration

Catheter ablation procedure time

Time frame
On day of ablation

Other outcomes

Sponsors and contacts

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Ottawa Heart Institute Research Corporation

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Abbott

Collaborator