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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Abbott | INDUSTRY |
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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.
This study is a randomized controlled trial evaluating two different catheter ablation strategies for patients with paroxysmal atrial fibrillation (AF). Participants are randomly assigned in a 1:1 ratio to either the control arm or the experimental arm prior to undergoing their ablation procedure. In the control arm, patients receive a pulmonary vein isolation (PVI)-only strategy using pulsed field ablation (PFA). This approach targets only the pulmonary veins, which are the most common source of AF triggers, and does not include additional ablation beyond isolating these veins. In contrast, the experimental arm uses a more comprehensive PVI-PLUS strategy with radiofrequency ablation (RFA). In addition to standard pulmonary vein isolation, this strategy includes patient-specific ablation of non-pulmonary vein triggers and abnormal atrial substrate, such as low-voltage areas identified during electrophysiologic testing. This individualized approach aims to reduce arrhythmia recurrence by addressing additional sources of AF beyond the pulmonary veins.
All participants undergo their assigned catheter ablation procedure as part of routine clinical care, with procedural details tailored according to the randomized strategy. Following the ablation, patients receive an implantable loop recorder (ILR), which is a small device placed under the skin that continuously monitors heart rhythm. The ILR allows for continuous, long-term detection of atrial arrhythmias, including both symptomatic and asymptomatic episodes, ensuring accurate assessment of treatment outcomes throughout the study period.
Participants are followed closely for a total of 24 months after the ablation procedure. During this follow-up period, patients attend scheduled visits at 2, 6, 12, 18, and 24 months, where ILR data are reviewed and clinical assessments are performed. The continuous monitoring provided by the ILR is central to evaluating the study's primary and secondary outcomes, including recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia. In addition to rhythm monitoring, patients complete quality-of-life questionnaires at baseline and at 24 months, and any repeat procedures, hospital visits, or complications are recorded. This structured follow-up ensures comprehensive evaluation of both the effectiveness and safety of the two ablation strategies over time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI-ONLY ablation | Active Comparator | Pulsed Field Ablation (PFA), control arm |
|
| PVI-PLUS ablation | Experimental | RADIOFREQUENCY CATHETER ABLATION (RFA), interventional arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVI-ONLY, CONTROL ARM | Procedure | PULSED FIELD ABLATION (PFA) PVI-ONLY STRATEGY: CONTROL ARM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial fibrillation, atrial flutter or atrial tachycardia | AF, AFl or AT, symptomatic or asymptomatic lasting ≥ 30 seconds | 61 to 730 days after ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation burden | Total duration of AF recorded on ambulatory monitoring/total duration of monitoring | 730 days |
| Long-term rate of documented atrial fibrillation, atrial flutter or atrial tachycardia |
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Inclusion Criteria:
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).
At least one episode of AF documented on 12-lead ECG, Holter monitor, Trans-telephonic monitor (TTM) or Loop Recorder.
Subjects must be able to provide informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Girish Nair, MD | Contact | 613-696-7272 | GNair@ottawaheart.ca | |
| Sonya Jancar | Contact | 613-696-7000 | 19678 | sjancar@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Girish Nair, MD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | K1Y 4W7 | Canada |
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Single-blind, prospective, randomized
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Participant only blinded to the treatment arm.
| PVI-PLUS ARM, INTERVENTIONAL ARM | Procedure | RADIOFREQUENCY CATHETER ABLATION (RFA) PVI-PLUS : INTERVENTION ARM |
|
Long-term rate of documented AF, AFl or AT lasting ≥ 30 seconds
| 730 days |
| 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 | First 60 days after catheter ablation |
| Ablation procedure duration | Catheter ablation procedure time | On day of ablation |
| Fluoroscopic exposure | Fluoro time in minutes | On day of ablation |
| Composite Safety outcomes | Procedure Related Complications at any time including Stroke, PV stenosis, pericarditis, phrenic nerve palsy, cardiac perforation, atrio-esophageal fistula, major bleeding and/or death. | 730 days |
| Emergency room visits or hospitalization due to recurrent atrial fibrillation, atrial flutter or atrial tachycardia | Emergency room visits or hospitalization due to recurrent atrial fibrillation, atrial flutter or atrial tachycardia | 730 days |
| Repeat catheter ablation for atrial fibrillation, atrial flutter or atrial tachycardia | Repeat catheter ablation for atrial fibrillation, atrial flutter or atrial tachycardia | 730 days |
| Quality of life scale | EuroQol 5-Dimension questionnaire (EQ-5D), scale of 0-100, higher is better perceived health. | 12 and 24 months |
| Health Economic analyses | Health Economic analyses | 730 days |
| Cumulative duration of Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia (atrial burden) | Cumulative duration of AF, AFL or AT (atrial burden) from day 61 after interventions to end of follow-up | Day 61- Day 730 |
| Comparison of primary outcome events between patients undergoing PVI-ONLY and PVI-PLUS | Comparison of primary outcome events (freedom from atrial fibrillation, atrial flutter or atrial tachycardia) between patients undergoing PVI only (due to lack of additional triggers/substrate) in the PVI-PLUS strategy and those in the PVI-ONLY group. | 730 days |
| Fluoroscopic exposure | Total Air Kerma | On day of ablation |
| Fluoroscopic exposure | Dose Area Protocol. | On day of ablation |
| Quality of life scale | Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT), 0-100 score range, 100 - no impairment, and 0-very poor quality of life. | 12 and 24 months |
| Quality of life scale | Canadian Cardiovascular Society Severity of Atrial Fibrillation (CCS-SAF), score range 0-4, higher score being worse symptoms, or greater impairment. | 12 and 24 months |
| McGill University Health Center | Not yet recruiting | Montreal | Quebec | H3G 1A4 | Canada |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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