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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI alone | Active Comparator | Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation |
|
| PVI and PWI | Active Comparator | Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation | Procedure | Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keisuke Okawa, MD | Kagawa Prefectural Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kagawa Prefectural Central Hospital | Takamatsu | Kagawa-ken | 760-8557 | Japan |
The data that support the findings of this study will be available from the data center upon reasonable request.
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| Left posterior wall isolation | Procedure | Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation |
|
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 |
| 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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