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Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal atrial fibrillation. However, it is not certain that cryoablation is effective and safe in patients with persistent atrial fibrillation, because of higher chance of recurrence compared to paroxysmal atrial fibrillation. The aim of this study is to evaluate the efficacy and safety of cryoballoon pulmonary vein isolation vs. cryoballoon pulmonary vein isolation with additional right atrial linear ablation for paroxysmal atrial fibrillation in a prospective randomized trial
A. Study design
Cryoballoon PV isolation group
Cryoballoon PV isolation with Additional RA linear ablation group
B. Progress and rhythm/ECG follow-up
C. Follow-up Patients were followed up for a minimum of 12 months after ablation. All the patients will be followed-up at 1, 3, 6, and 12 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.
9. Observation Items • Clinical Test Items and Observation Method A. Disease name, age, gender, weight, height, disease duration B. Evaluation of comorbid structural heart disease pattern C. Evaluation of clinically significant comorbid disease pattern D. Imaging quantitative assessment (All the examinations will be performed according to the need for treatment, regardless of the purpose of the study, and no additional imaging tests will be performed for study purposes.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoballoon PV isolation group | Active Comparator |
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| Cryoballoon PV isolation w/ RA linear ablation group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon PV isolation group | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of any atrial arrhythmia | Recurrence of any atrial arrhythmia (Defined as atrial fibrillation, atrial tachycardia, or atrial flutter lasting at least 30 seconds after a 3-month post-procedure blanking period | up to 24 months with a minimum of 12 months follow up after a single ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | immediate after procedure | |
| Anti-arrhythmic drug use after a 3-month blanking period | up to 24 months with a minimum of 12 months follow up after a single ablation procedure. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hui-Nam Pak | Yonsei University Health System, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Cardiovascular Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
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Sample Size Determination A. 276 subjects will be enrolled in this study. After enrollment, subjects will be randomized in a 1:1 fashion to Cryoballoon PV isolation group (138 subjects) or Cryoballoon PV isolation group with additional RA linear ablation group (138 subjects).
B. The difference in the recurrence of atrial fibrillation between the two groups will be identified based on the data, with 80% statistical power and a 5% two-sided alpha error rate, to examine the 16% estimated difference between the groups, considering an about 5% dropout rate. The clinical recurrence rate of atrial fibrillation in the general control group was set at 39.3% considering the existing literature and the data of this hospital.
C. Statistical hypothesis: There is a significant difference in the clinical recurrence and risk of complications after cryoballoon pulmonary vein isolation and additional right atrial linear ablation for persistent atrial fibrillation.
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| Cryoballoon PV isolation with Additional RA linear ablation group | Procedure |
|
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| Recurrence of any atrial arrhythmia lasting at least 30 seconds occurring after a 3-month blanking period or anti-arrhythmic drug use after a 3-months blanking period |
| up to 24 months with a minimum of 12 months follow up after a single ablation procedure. |
| Number of patients with recurrence as atrial fibrillation | up to 24 months with a minimum of 12 months follow up after a single ablation procedure. |
| Number of patients with recurrence as atrial tachycardia/flutter | up to 24 months with a minimum of 12 months follow up after a single ablation procedure. |
| Procedural complications | immediate after procedure |
| Proportion of cardioversion performed among patients with the recurrence of atrial arrhythmia. | up to 24 months with a minimum of 12 months follow up after a single ablation 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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