STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

Study Overview
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Brief Summary
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The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF: PV antral isolation alone (PVAI) PV antral isolation plus ablation of drivers (PVAI+drivers) PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

Official Title
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Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
* Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
* Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 years of age or older Patients undergoing first-time ablation procedure for AF Patients with persistent AF defined as a sustained episode more than 3 months but less than three years Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms or any combination of the above Patients whose AF has been refractory to at least one antiarrhythmic drug At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment Patients must be able and willing to provide written informed consent to participate in the study Exclusion Criteria: Patients with paroxysmal AF (no episodes lasting > 7 days) Patients with early persistent AF, sustained episode ≤ 3 months Patients with very long lasting persistent AF (episodes lasting > 3 years) Patients with CHA2DS2-VASc score of 0. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued Patients with AF felt to be secondary to an obvious reversible cause Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin Patients with left atrial diameter > 60 mm in the parasternal long axis view Patients who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PV antral isolation alone (PVAI)<br>PV antral isolation alone (PVAI) | Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)<br>* Standard PVI<br>|
| Active Comparator: PV antral isolation plus ablation of drivers<br>PV antral isolation plus ablation of drivers (PVAI+drivers) | Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)<br>* Standard PVI + Ablation of drivers in LA and RA<br>|
| Active Comparator: PV antral isolation plus isolation of posterior wall<br>PV antral isolation plus isolation of LA posterior wall (PVAI+Box) | Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)<br>* Standard PVI + Electrical isolation of the posterior wall of the left atrium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM). |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM |  | 18 months | 
| Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM |  | 18 months | 
| Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM |  | 18 months | 
| Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM |  | 18 months | 
| Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM |  | 18 months | 
| Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM |  | 18 months | 
| Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM |  | 18 months | 
| Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM |  | 18 months | 
| Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM |  | 18 months | 
| Each of the above success measures stratified by CHA2DS2-VASc score |  | 18 months | 
| Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death |  | 18 months | 
| Procedure duration |  | 18 months | 
| Fluoroscopy time (dose) |  | 18 months | 
| Radiofrequency time |  | 18 months | 
| Number of repeat procedures |  | 18 months | 
| Effect of each strategy on AF cycle length changes and AF termination |  | 18 months | 
| Correlation of acute AF termination on long-term procedural outcome |  | 18 months | 
| Quality of life measurements during follow-up using AFEQT questionnaire | AFEQT questionnaires will be used at baseline, 6, 12 and 18 months | 6-12-18 months | 
| Quality of life measurements during follow-up using SF36 questionnaires | SF36 questionnaires will be used at baseline, 6, 12 and 18 months | 6-12-18 months | 
| Change in AF burden post-ablation procedure (% of time in AF) |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ablation