Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Efficacy of Atrial Fibrillation Catheter Ablation(AFCA)
研究概览
简要总结
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.
详细描述
Study design
- Prospective randomization (AI-based patient selection group vs. conventional guidelines-based patient selection group)
- Target number of subjects 1000 patients (500 people in each group)
- Rhythm follow-up schedule: 2012 ACC/AHA/ESC guidelines (basal, 3 months, then every 6 months Holter, ECG when symptomatic)
- Anticoagulant therapy follows 2020 ESC guidelines.
- Evaluation of all adverse events occurring in each group and comparative evaluation of hospitalization rates, major cardiovascular attacks, and mortality
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left atrium size < 55 mm
- •AF recurred during the administration of antiarrhythmic drugs or that antiarrhythmic drugs intolerable patients
- •Patients eligible for anticoagulant therapy (to prevent thromboembolic events)
排除标准
- •AF associated with severe cardiac anomalies or structural heart disease with hemodynamic influence
- •Patients who have difficulty in CT imaging using a contrast medium
- •Patients with active internal bleeding
- •Inappropriate anticoagulant therapy
- •Serious comorbidities
- •Patients expected to survive less than 1 year
- •People with drug or alcohol addiction
- •Those who cannot read the consent form (illiterate, foreigners, etc.)
- •Patients who are judged unsuitable for participation in clinical research by the judgment of other investigators
结局指标
主要结局
Efficacy of Atrial Fibrillation Catheter Ablation(AFCA)
时间窗: Up to 5 years
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
safety of Atrial Fibrillation Catheter Ablation(AFCA)
时间窗: Up to 5 years
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)
次要结局
- number of electrical cardioversion after the procedure(1 week, 3, 6, 12, 18, 24, 36 months after procedure)
- Re-hospitalization rate of electrical cardioverson after the procedure(1 week, 3, 6, 12, 18, 24, 36 months after procedure)
- 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)
- Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure(Immediate after procedure)