New parameters or methods, such as ablation index, have been developed for the quantification of high-frequency energy used in pulmonary vein isolation, but there is no known method for atrial fibrillation considering individual differences in atrial tissue. The atrium is only 1/3 of the thickness of the ventricle and is thinner in women and older than men or young people.
The aim of this study was to evaluate the efficacy and safety of radiofrequency energy therapy using atrial individual differences. In order to reflect the thickness of the atrium, we will use the unipolar and bipolar maps and the myocardial thickness map using computed tomography (CT) images. To evaluate the efficacy and safety of energy titration therapy by random assignment of high frequency energy therapy group, CT image application high frequency energy therapy group, and existing empirical high frequency therapy group.
Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥20 and ≤80 years of age
Left atrium size < 50mm
paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Patients with persistent or permanent atrial fibrillation
Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
Patients with severe renal impairment or CT imaging difficulty using contrast media
Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
Parallel
Unipolar voltage subtraction map guided PV isolation group
Procedure/Surgery1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury 3. Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture 4. the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes) 5. Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map 6. Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map 7. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 8. Evaluate time to complete isolation after additional ablation 9. Evaluation of Procedure and Ablation time, and perfusion saline dose 10. Rhythm follow-up after the procedure in accordance with the study design.
CT myocardial thickness map guided PV isolation group
Procedure/Surgery1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. Prepared myocardial thickness map with CT DICOM images conducted prior to procedure. 4. Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map 5. Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map 6. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 7. Evaluate time to complete isolation after additional ablation 8. Evaluation of Procedure time, Ablation time, and perfusion saline dose 9. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
Empirical PV isolation group
Procedure/Surgery1. Pulmonary vein isolation will be performed using a radiofrequency catheter 2. Esophageal temperature will be monitored to prevent esophageal injury. 3. The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner. 4. Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection 5. Evaluate time to complete isolation after additional ablation 6. Evaluation of Procedure time, Ablation time, and perfusion saline dose 7. Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design.
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.
Efficacy evaluation: Atrial fibrillation or atrial tachycardia for at least 30 seconds after 3 months within 1 year without antiarrhythmic medication
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
Efficacy evaluation: Major cardiovascular event rate
death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Efficacy evaluation: Major cardiovascular event rate
death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Comparison of procedure time
Comparison of ablation time
Comparison of hospitalization period
Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate
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