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Cryoballoon ablation is proven to be effective in pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation. We previously reported that the rhythm outcome of radiofrequency (RF) catheter ablations are equivalent in patients with non-valvular atrial fibrillation and in those with surgically and hemodynamically corrected valvular atrial fibrillation. In contrast, the Cryoballoon ablation can reduce the procedure times, it cannot conduct empirical linear ablation or extra-pulmonary vein foci ablation. The aim of this study is to compare Cryoballoon pulmonary vein isolation and RF ablation including linear ablation or extra-pulmonary vein foci ablations in patients with hemodynamically corrected valvular atrial fibrillation.
A. Study design
B. Progress and rhythm/ECG follow-up
C. Follow-up All the patients will be followed-up at 1 weeks, 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 3, 6 months, and thereafter 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 |
|---|---|---|---|
| Cryoballoon Pulmonary Vein isolation | Experimental |
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| Radiofrequency Pulmonary Vein isolation | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryoballoon Pulmonary Vein isolation | Procedure |
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| 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 3 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of procedure time | immediate after procedure | |
| Comparison of ablation time | immediate after procedure | |
| Comparison of hospitalization period |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Cardiovascular Hospital, Yonsei University Health System | Seoul | 120-752 | South Korea |
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| Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation | Procedure |
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| immediate after procedure |
| Comparison of re-hospitalization rate after the procedure | immediate after procedure |
| Comparison of re-hospitalization rate after the procedure | 12 months after procedure |
| Comparison of number of electrical cardioversion after the procedure | immediate after procedure |
| Comparison of number of electrical cardioversion after the procedure | 12 months after procedure |
| Major cardiovascular event rate - death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure | immediate after procedure and 12 months after procedure |