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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.
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 |
|---|---|---|---|
| Unipolar voltage subtraction map guided PV isolation group | Experimental |
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| CT myocardial thickness map guided PV isolation group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unipolar voltage subtraction map guided PV isolation group | 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: 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 | 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 |
|---|---|---|
| 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 | Recruiting | Seoul | 120-752 | South Korea |
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| Empirical PV isolation group |
| Active Comparator |
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| CT myocardial thickness map guided PV isolation group | Procedure |
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| Empirical PV isolation group | Procedure |
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| immediate after procedure |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate | 1 week after procedure |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate | 3 months after procedure |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate | 6 months after procedure |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate | 12 months after procedure |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate | 18 months after procedure |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate | 24 months after procedure |
| Comparison of anti-arrhythmic drug or anticoagulation therapy related complication rate | 36 months after procedure |
| Comparison of re-hospitalization rate after the procedure | 1 week after procedure |
| Comparison of re-hospitalization rate after the procedure | 3 months after procedure |
| Comparison of re-hospitalization rate after the procedure | 6 months after procedure |
| Comparison of re-hospitalization rate after the procedure | 12 months after procedure |
| Comparison of re-hospitalization rate and number of electrical cardioversion after the procedure | 18 months after procedure |
| Comparison of re-hospitalization rate after the procedure | 24 months after procedure |
| Comparison of re-hospitalization rate after the procedure | 36 months after procedure |
| Comparison of number of electrical cardioversion after the procedure | 1 week months after procedure |
| Comparison of number of electrical cardioversion after the procedure | 3 months after procedure |
| Comparison of number of electrical cardioversion after the procedure | 6 after procedure |
| Comparison of number of electrical cardioversion after the procedure | 12 months after procedure |
| Comparison of number of electrical cardioversion after the procedure | 18 months after procedure |
| Comparison of number of electrical cardioversion after the procedure | 24 months after procedure |
| Comparison of number of electrical cardioversion after the procedure | 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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