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

Yonsei University

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: Medical Therapy; Procedure: Artificial Intelligence-based atrial fibrillation catheter ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT04997824

4-2021-0608

Details and patient eligibility

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.

Full description

Study design

1. Prospective randomization (AI-based patient selection group vs. conventional guidelines-based patient selection group)
2. Target number of subjects 1000 patients (500 people in each group)
3. Rhythm follow-up schedule: 2012 ACC/AHA/ESC guidelines (basal, 3 months, then every 6 months Holter, ECG when symptomatic)
4. Anticoagulant therapy follows 2020 ESC guidelines.
5. 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

1. Implemented according to 2012 American College of Cardiology(ACC)/American Heart Association(AHA)/Heart Rhythm Society(HRS) guidelines for AF management
2. Outpatient follow-up 1 to 2 weeks after the start of the procedure or drug treatment
3. Follow-up every 3 months after the procedure, and every 6 months thereafter
4. If the patient complains of arrhythmia symptoms, conduct an electrocardiogram at any time and follow the rhythm with a Holter or an event recorder.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Left atrium size < 55 mm
2. AF recurred during the administration of antiarrhythmic drugs or that antiarrhythmic drugs intolerable patients
3. Patients eligible for anticoagulant therapy (to prevent thromboembolic events)

Exclusion criteria

1. AF associated with severe cardiac anomalies or structural heart disease with hemodynamic influence
2. Patients who have difficulty in CT imaging using a contrast medium
3. Patients with active internal bleeding
4. Inappropriate anticoagulant therapy
5. Serious comorbidities
6. Patients expected to survive less than 1 year
7. People with drug or alcohol addiction
8. Those who cannot read the consent form (illiterate, foreigners, etc.)
9. Patients who are judged unsuitable for participation in clinical research by the judgment of other investigators

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Artificial Intelligence-based atrial fibrillation catheter ablation

Experimental group

Description:

catheter ablation

Treatment:

Procedure: Artificial Intelligence-based atrial fibrillation catheter ablation

Medical Therapy

Active Comparator group

Description:

catheter ablation

Treatment:

Procedure: Medical Therapy