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

NCT04997824 | Recruiting DMC

• 1 other identifier: 4-2021-0608
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Efficacy of Atrial Fibrillation Catheter Ablation(AFCA)

  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

  Up to 5 years

• safety of Atrial Fibrillation Catheter Ablation(AFCA)

  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)

  Up to 5 years

Secondary Outcomes (5)

• Comparison of procedure time, ablation time and hospitalization period

  Immediate after procedure

• Anti-arrhythmic drug or anticoagulation therapy related complication rate

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

• Re-hospitalization rate of electrical cardioverson after the procedure

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

• number of electrical cardioversion after the procedure

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

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

  Immediate after procedure

Study Arms (2)

Artificial Intelligence-based atrial fibrillation catheter ablation

EXPERIMENTAL

catheter ablation

Procedure: Artificial Intelligence-based atrial fibrillation catheter ablation

Medical Therapy

ACTIVE COMPARATOR

catheter ablation

Procedure: Medical Therapy

Interventions

Artificial Intelligence-based atrial fibrillation catheter ablation PROCEDURE

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.

Artificial Intelligence-based atrial fibrillation catheter ablation

Medical Therapy PROCEDURE

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

Medical Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hui-Nam Pak

  Severance Hospital, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Nam Pak

CONTACT

82-2-2228-8459; hnpak@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 10, 2021
• Study Start: October 7, 2021
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

KR (1)