Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
Recruiting · NCT04997824 · Interventional (participants receive a specific treatment) · Lead sponsor: Yonsei University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Severance Hospital, Yonsei University Health System - Seoul, South Korea