Clinical trial NCT04997824: Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
Official title: Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of Atrial Fibrillation Catheter Ablation(AFCA)
timeFrame: Up to 5 years
measure: safety of Atrial Fibrillation Catheter Ablation(AFCA)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Comparison of procedure time, ablation time and hospitalization period
timeFrame: Immediate after procedure
measure: Anti-arrhythmic drug or anticoagulation therapy related complication rate
timeFrame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
measure: Re-hospitalization rate of electrical cardioverson after the procedure
timeFrame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
measure: number of electrical cardioversion after the procedure
timeFrame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
measure: Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
timeFrame: Immediate after procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital, Yonsei University Health System
name: Hui-Nam Pak
role: PRINCIPAL_INVESTIGATOR
References: