Left Atrial Posterior Wall Additional Isolation for Persistent Atrial Fibrillation Trial

Study Overview
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Brief Summary
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The purpose for this study is to determine whether left posterior wall isolation (PWI) in addition to pulmonary vein isolation (PVI) is effective as ablation strategy for persistent atrial fibrillation (AF).

Detailed Description
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PVI is cornerstone of AF ablation. However, clinical outcome of only PVI in patients with persistent AF is insufficient due to AF substrate extending to left atrium. Strategy of catheter ablation for persistent AF is not established despite attempts of numerous left atrial substrate modifications. Additional PWI on PVI is one of expected effective strategies for persistent AF, because PW originated from common tissue of PV and is considered to play a part in AF trigger and maintenance. However, this strategy is also not established in the recent international consensus statement. Following two reasons are considered. One is the procedural difficulty in creating durable PWI, and another is the existence of patients who can recover by only PVI. The latest technology, ablation index, can create durable PVI, and may create durable PWI. Several reports suggested that PVI only strategy was sufficient in the patients with persistent AF who could maintain sinus rhythm after pharmacological or electrical cardioversion. Therefore, we planed this randomized clinical trial that compared between PVI alone and additional PWI on PVI using ablation index in the patients with persistent AF without pharmacological sinus rhythm conversion.

Official Title
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Randomized Clinical Trial of Additional Left Atrial Posterior Wall Isolation for Persistent Atrial Fibrillation

Conditions
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Persistent Atrial Fibrillation, Catheter Ablation, Pulmonary Vein Isolation, Posterior Wall Isolation

Intervention / Treatment
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* Procedure: Pulmonary vein isolation
* Procedure: Left posterior wall isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for first catheter ablation of persistent atrial fibrillation Patients without conversion to sinus rhythm within 30 days after antiarrhythmic drug administration Patients with persisting duration of atrial fibrillation less than 3 years Patients with left atrial diameter less than 50mm Patients who can be followed up for 18 months Patients with written informed consent Exclusion Criteria: Patients who can not be received adequate anticoagulation therapy Patients with history of myocardial infarction within 6 months Patients with history of open heart surgery Patients scheduled for open heart surgery Patients with severe valvular heart disease Patients during pregnancy Patients with expected life expectancy less than 1 year due to malignancy or non-cardiovascular disease Patients considered unsuitable for study by the attending physician

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI alone<br>Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation | Procedure: Pulmonary vein isolation<br>* Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation<br>|
| Active Comparator: PVI and PWI<br>Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation | Procedure: Left posterior wall isolation<br>* Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial tachyarrhythmia after 90-day blanking period of catheter ablation | Recurrence of atrial tachyarrhythmia is defined atrial arrhythmia that needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of catheter ablation | Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds. | 18 months | 
| Recurrence of atrial fibrillation or atrial tachycardia within 90-day after catheter ablation | Recurrence of atrial fibrillation or atrial tachycardia needs admission, electrical cardioversion, and antiarrhythmic drug administration, and/or that persists more than 30 seconds. | 90 days | 
| Repeated ablation of atrial tachyarrhythmia |  | 18 months | 
| Recurrence of atrial fibrillation or atrial tachycardia after 90-day blanking period of repeated ablation |  | 18 months | 
| Atrial Fibrillation Quality of Life Questionnaire | Atrial Fibrillation Quality of Life Questionnaire | 18 months | 
| Complications of ablation procedure | Complications of ablation procedure includes death, cardiac tamponade, pericardial effusion, systemic embolism, symptomatic strokes, hematoma, A-V shunt, pericarditis, phrenic nerve paralysis, A-V block, procedure-related infections, heart failure, atrio-esophageal fistula, esophageal vagus nerve injury | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter ablation, Persistent atrial fibrillation, Pulmonary vein isolation, Posterior wall isolation