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Atrial fibrillation (AF) is a major cardiovascular disease with a prevalence of 1.7% of the total population in Korea, associated with 25% of ischemic stroke and 30% of heart failure, and is a major cardiovascular disease that doubles the risk of dementia. AF catheter ablation (AFCA) is an effective procedure that lowers the risk of heart failure mortality and cerebral infarction and improves cognitive or renal functions. However, the recurrence rate after the procedure is relatively high, especially in patients with long-standing persistent AF in which atrial remodeling has already progressed. Research on the prediction of treatment efficacy using artificial intelligence (AI) is being actively conducted around the world. We predicted the AFCA poor responders who will progress to permanent AF despite AFCA among a total of 3,372 patients included in the Yonsei AF Ablation cohort and the 2nd independent cohort with a long-term follow-up through AI with area under curve (AUC) 0.943. Therefore, in this prospective randomized clinical study, the difference between the patient selection for AFCA using AI algorithm and the clinical guidelines-based decision will be compared and evaluated in terms of long-term rhythm outcome.
Study design
Process of Patient Selection A guideline-based appropriate candidate for AFCA Randomization for AI-guide group vs. Clinical guideline-based group Poor responder selection by AI at the outpatient clinic AI-prediction outcomes should be noticed in AI-guided groups, but not in the clinical guideline-based group.
Recommendation of rate control for AI-predicted poor responders All-comer ablation in guideline-based group
Progress and rhythm/ECG tracking
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Intelligence-based atrial fibrillation catheter ablation | Experimental | catheter ablation |
|
| Medical Therapy | Active Comparator | catheter ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence-based atrial fibrillation catheter ablation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Atrial Fibrillation Catheter Ablation(AFCA) | Efficacy evaluation: Clinical recurrence rate - Defined as AF or atrial tachycardia lasting over 30 seconds after 3 months of procedure. Rhythm monitoring based on 2012 ACC/AHA/HRS guidelines as described above. 24-hour Holter ECG monitoring will be performed at 2-3 month and every 6 months within 2 years of procedure, Holter every 1 year after 2 years of procedure and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms | Up to 5 years |
| safety of Atrial Fibrillation Catheter Ablation(AFCA) | Safety Assessment: Incidence of procedure-related complications within 30 days of procedure (thoracotomy, cerebral infarction, pericardial effusion or pericardial tamponade, inguinal puncture site hematoma, and vascular complications) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of procedure time, ablation time and hospitalization period | Immediate after procedure | |
| Anti-arrhythmic drug or anticoagulation therapy related complication rate | 1 week, 3, 6, 12, 18, 24, 36 months after procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Nam Pak | Contact | 82-2-2228-8459 | hnpak@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Hui-Nam Pak | Severance Hospital, Yonsei University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | South Korea |
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|
| Medical Therapy | Procedure |
|
|
| Re-hospitalization rate of electrical cardioverson after the procedure | 1 week, 3, 6, 12, 18, 24, 36 months after procedure |
| number of electrical cardioversion after the procedure | 1 week, 3, 6, 12, 18, 24, 36 months after procedure |
| Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure | Immediate 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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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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