AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique)

Study Overview
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Brief Summary
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Recent publications suggest that neither empirical nor individualized substrate modification strategies could improve single-procedure efficacy beyond pulmonary vein (PV) isolation for persistent atrial fibrillation (AF). However, persistent AF represent a broad spectrum of the same disease and if PV isolation may be sufficient for some patient with self-terminated AF or with a small left atrium, a more extended substrate ablation may be required for other patients, for which a second procedure for atrial tachycardia (AT) recurrence is then frequently needed. In addition, a lot of progress has recently been made in the field of ablation techniques using contiguous and optimized ablation radiofrequency (RF) lesions and also for AT mapping with promising results using repetitive but discontinuous Holter monitoring. This trial aims at To objectively compare atrial tachyarrhythmia (ATA) burden > 2 months before ablation and after one or two 'CLOSEMAZE'-guided ablation(s) using continuous monitoring and echo data as a guide for the ablation strategy during the first ablation. To assess ATA burden using continuous monitoring up to 3 years after ablation. To identify baseline structural and electrical properties of the atria or procedural characteristics that predict 1-year and 3-year outcome.

Official Title
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AF Burden and Echo-guided Persistent AF Ablation Strategy Using Either PV Isolation Alone (CLOSE Protocol) or Optimized Compartmentalization of the Left Atrium (Pseudo-maze Technique): the CLOSEMAZE Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: PVI only
* Procedure: PVI with substrate ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with symptomatic persistent AF (history of continuous AF > 7 days), meeting following criteria at the out-patient clinic: patient has AF at the time of the visit AF episodes are symptomatic, and patient is drug-resistant (at least one class Ic or III), or drug-intolerant (palpitations, fatigue, dyspnea, cardiomyopathy,…) If the patient has heart failure (LVEF<50%), first line AF ablation (instead of amiodarone) is indicated Signed Patient Informed Consent Form. Age 18 years or older. Able and willing to comply with all follow-up testing and requirements. Exclusion Criteria Longstanding persistent atrial fibrillation (Suspected continuous AF>1 year) Previous ablation for AF left atrial antero-posterior diameter > 55 mm (parasternal long axis view (PLAX)) LVEF < 30% (ejection fraction) AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause Coronary artery bypass graft within the last three months Awaiting cardiac transplantation or other cardiac surgery Documented left atrial thrombus on imaging Diagnosed atrial myxoma Women who are pregnant or breastfeeding Acute illness or active systemic infection or sepsis Unstable angina Uncontrolled heart failure Myocardial infarction within the previous two months History of blood clotting or bleeding abnormalities Contraindication to anticoagulation therapy (ie, heparin or warfarin) Life expectancy less than 12 months Enrollment in any other study evaluating another device or drug Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulmonary vein isolation (PVI) only<br> | Procedure: PVI only<br>* Patients in this group receive PVI only<br>|
| Active Comparator: PVI with substrate<br> | Procedure: PVI with substrate ablation<br>* Patients in this group receive PVI as well as substrate ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial tachyarrhythmia (ATA) burden before and after 'CLOSEMAZE'-guided based ablation and off anti-arrhythmic drug (AAD) therapy | ATA burden (= time that a subject experiences AF) will be monitored with continuous loop recording (CLR) from time of CLR implant until 3 years after ablation | CLR implant to 3 year post ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial tachyarrhythmia burden after one CLOSEMAZE guided ablation | ATA burden after first ablation documented through continuous loop recordings | 3 years after ablation | 
| Atrial tachyarrhythmia burden after two CLOSEMAZE guided ablation | ATA burden after two ablations documented through continuous loop recordings | 3 years after ablation |