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NCT Number: NCT04997824

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location status: Recruiting

Location contact

Hui-Nam Pak

CONTACT

[email protected]

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About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial Intelligence-based atrial fibrillation catheter ablation

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

Medical Therapy

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

Primary outcomes

  1. Efficacy of Atrial Fibrillation Catheter Ablation(AFCA)

    Time frame: 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

  2. safety of Atrial Fibrillation Catheter Ablation(AFCA)

    Time frame: 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)

Secondary outcomes

  1. Comparison of procedure time, ablation time and hospitalization period

    Time frame: Immediate after procedure

  2. Anti-arrhythmic drug or anticoagulation therapy related complication rate

    Time frame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure

  3. Re-hospitalization rate of electrical cardioverson after the procedure

    Time frame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure

  4. number of electrical cardioversion after the procedure

    Time frame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure

  5. Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure

    Time frame: Immediate after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Nam Pak

CONTACT

[email protected]

82-2-2228-8459

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Aug 10, 2021
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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