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Catheter ablation for atrial fibrillation (AF) is an effective rhythm control method that shows superior rhythm outcome than antiarrhythmic drug (AAD) treatment in drug-resistant AF. However, AF catheter ablation still has a substantial recurrence rate.
The current AAD use guidelines for AF management focus on the safety of drug use. However, if the AAD efficacy evaluation system using computer modeling reflecting the individual anatomy, electrophysiology, and histological characteristics of patients is practical, it will help to select a more effective AAD type or dose.
The purpose of this study is to conduct a prospective randomized clinical study on the efficacy and safety of computer modeling for optimal AAD selection in patients with recurrent AF after catheter ablation. The investigator will evaluate the efficacy of AAD simulations by comparing virtual AAD effect guided therapy and empirical AAD use in patients with recurrent AF after AF catheterization.
The investigator will test the virtual AAD effects in the computer simulations integrated by cardiac images and 3D electrophysiological maps obtained during de novo AF ablation. The investigator will compare the effects of the most potent AAD selected by virtual AAD simulation with those of empirical AAD.
A. Study design
B. Progress and rhythm/ECG follow-up
C. Follow-up All the patients will be followed-up at 2 weeks, 2, 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 2months and 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 |
|---|---|---|---|
| Virtual AAD TEST group | Experimental |
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| Empirical AAD group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual AAD TEST group | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy evaluation: clinical recurrence rate | Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 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 | At 2 months after medication |
| Efficacy evaluation: clinical recurrence rate | Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 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 | At 6months after medication |
| Efficacy evaluation: clinical recurrence rate | Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 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 | At 12 months after medication |
| Efficacy evaluation: clinical recurrence rate | Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 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 | At 18 months after medication |
| Efficacy evaluation: clinical recurrence rate | Defined as atrial fibrillation or atrial tachycardia > 30 sec after medication within 2 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of cardioversion frequency | comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage) | At 2 months after medication |
| Comparison of cardioversion frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Nam Park | Contact | 82-2-2228-8459 | hnpak@yuhs.ac |
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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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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Empirical AAD group | Drug |
|
|
| At 24months after medication |
| Safety evaluation: Major cardiovascular event rate after medication | Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage | At 2 months after medication |
| Safety evaluation: Major cardiovascular event rate after medication | Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage | At 6 months after mediation |
| Safety evaluation: Major cardiovascular event rate after medication | Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage | At 12 months after mediacation |
| Safety evaluation: Major cardiovascular event rate after medication | Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage | At 18 months after mediacation |
| Safety evaluation: Major cardiovascular event rate after medication | Death, Hospitalization, Systemic embolism related atrial fibrillation, Cerebrovascular disease, Stroke, Hemorrhage | At 24 months after mediacation |
comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage) |
| At 6 months after medication |
| Comparison of cardioversion frequency | comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage) | At 12 months after medication |
| Comparison of cardioversion frequency | comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage) | At 18 months after medication |
| Comparison of cardioversion frequency | comparison of cardioversion fequency after medication (including re-hospitalization for complication by heart failure, embolism and hemorrhage) | At 24 months after medication |
| re-ablation(RFCA) fequency | re-ablation(RFCA) fequency after medication. | At 2 months after medication |
| re-ablation(RFCA) fequency | re-ablation(RFCA) fequency after medication. | At 6 months after medication |
| re-ablation(RFCA) fequency | re-ablation(RFCA) fequency after medication. | At 12 months after medication |
| re-ablation(RFCA) fequency | re-ablation(RFCA) fequency after medication. | At 18 months after medication |
| re-ablation(RFCA) fequency | re-ablation(RFCA) fequency after medication. | At 24months after medication |
| Rate of re-hospitalization | Rate of re-hospitalization after medication | At 2 months after medication |
| Rate of re-hospitalization | Rate of re-hospitalization after medication | At 6 months after medication |
| Rate of re-hospitalization | Rate of re-hospitalization after medication | At 12 months after medication |
| Rate of re-hospitalization | Rate of re-hospitalization after medication | At 18 months after medication |
| Rate of re-hospitalization | Rate of re-hospitalization after medication | At 24 months after medication |
| Frequency of drug complication | Frequency of drug complication after medication | At 2 months after medication |
| Frequency of drug complication | Frequency of drug complication after medication | At 6 months after medication |
| Frequency of drug complication | Frequency of drug complication after medication | At 12 months after medication |
| Frequency of drug complication | Frequency of drug complication after medication | At 18 months after medication |
| Frequency of drug complication | Frequency of drug complication after medication | At 24 months after medication |
| Rate of discontinuation of medication | Rate of discontinuation of medication due to complication | At 2 months after medication |
| Rate of discontinuation of medication | Rate of discontinuation of medication due to complication | At 6 months after medication |
| Rate of discontinuation of medication | Rate of discontinuation of medication due to complication | At 12 months after medication |
| Rate of discontinuation of medication | Rate of discontinuation of medication due to complication | At 18 months after medication |
| Rate of discontinuation of medication | Rate of discontinuation of medication due to complication | At 24 months after medication |
| D013568 |
| Pathological Conditions, Signs and Symptoms |