RecruitingNot ApplicableNCT04997824

Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)

Sponsor

Yonsei University

Enrollment

1,000 participants

Start Date

Oct 7, 2021

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

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.

Eligibility

Inclusion Criteria3

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)

Exclusion Criteria9

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

Interventions

PROCEDUREArtificial Intelligence-based atrial fibrillation catheter ablation

1. Patient selection for Atrial Fibrillation Catheter Ablation(AFCA) 2. AI-guided prediction for poor responder of AFCA in the outpatient clinic 3. Sharing information on the AI prediction with the patient and family member 4. AFCA after consent to the procedure 5. Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers 6. Monitoring esophageal temperature 7. Evaluation of Procedure and ablation time, and complication afer procedure 8. Post-procedure rhythm follow-up is carried out according to the study design above.

PROCEDUREMedical Therapy

1. Patient selection for Atrial Fibrillation Catheter Ablation(AFCA) 2. Decision for AFCA based on clinical guidelines and the experience of the attending physician 3. AFCA after consent to the procedure 4. Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers 5. Monitoring esophageal temperature 6. Evaluation of Procedure and ablation time, and complication afer procedure