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Although the additional linear ablation after pulmonary vein isolation (PVI) is a class IIB indication for AF catheter ablation in patients with persistent AF, no clear benefit has been demonstrated in the recent randomized clinical trials (STAR-AF2 or POBI trials). Nevertheless, in the retrospective cohort data of this research team, additional POBI and AL were helpful in persistent AF patients with left atrial (LA) size > 50mm or more or low LA voltage. The purpose of this study was to evaluate the efficacy and safety of additional POBI and AL compared to CPVI alone in persistent AF patients with LA size over 50mm. Also, we intend to proceed with this randomized clinical trial with the high power short duration ablation protocol, which is effective in shortening the procedure time.
A. Study design
B. Progress and rhythm/ECG follow-up
C. Follow-up All the patients will be followed-up at 1, 3, 6 months, and thereafter every 6 months. If the patient shows any symptom within the clinical study period, patient will visit the outpatient clinic. ECG will be performed at every outpatient visits, and 24-hour Holter or event recording will be performed every 6 months for 2 years, and every year after 2 years (2012 Heart Rhythm Society/EHRA/European Cardiac Arrhythmia Society Expert Consensus Statement guidelines). If atrial fibrillation or atrial tachycardia lasting more than 30 seconds is observed in 12-lead ECG or Holter, it will be evaluated as recurrence. Recurrence within 3 months after the procedure will be classified as early recurrence, and that after 3 months will be classified as clinical recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Circumferential pulmonary vein isolation(CPVI) group | Active Comparator |
| |
| Posterior box isolation(POBI) group | Experimental |
| |
| POBI+Anterior linear ablation(AL) group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circumferential pulmonary vein isolation(CPVI) group | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation: Procedure-related cardiac complication rate | -including open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications within 30 days post procedure. | within 30 days post procedure |
| Efficacy evaluation: clinical recurrence rate | - Defined as atrial fibrillation or atrial tachycardia > 30 sec after 3 months within 1 year; based on the 2012 ACC/AHA/HRS guidelines, 24-hour Holter ECG monitoring will be performed at 2 month and every 6 months, and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms | Within 1 year after 3 months of procedure |
| Efficacy evaluation: Major cardiovascular event rate | - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure | immediate after procedure |
| Efficacy evaluation: Major cardiovascular event rate | - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure | 12 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| procedure time | immediate after the procedure | |
| hospitalization duration | immediate after the discharge | |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Nam Pak | Contact | 82-2-2228-8459 | hnpak@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Hui-Nam Pak | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Severance Hospital | Seoul | South Korea |
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|
| Posterior box isolation(POBI) group | Procedure |
|
|
| POBI+Anterior linear ablation(AL) group | Procedure |
|
|
| immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure. |
| rate of electrical cardioversion | immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure. |
| rate of cardiovascular hospitalization | immediate after the procedure, 1 week, 3,6,12,18,24,36 months after procedure. |
| 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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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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