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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997824
• Other study ID #: 4-2021-0608
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: June 2031

Study information

• Verified date: May 2023
• Source: Yonsei University
• Contact: Hui-Nam Pak
• Phone: 82-2-2228-8459
• Email: hnpak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2031
• Est. primary completion date: June 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Artificial Intelligence-based atrial fibrillation catheter ablation
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
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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Comparison of procedure time, ablation time and hospitalization period		Immediate after procedure
Secondary	Anti-arrhythmic drug or anticoagulation therapy related complication rate		1 week, 3, 6, 12, 18, 24, 36 months after procedure
Secondary	Re-hospitalization rate of electrical cardioverson after the procedure		1 week, 3, 6, 12, 18, 24, 36 months after procedure
Secondary	number of electrical cardioversion after the procedure		1 week, 3, 6, 12, 18, 24, 36 months after procedure
Secondary	Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure		Immediate after procedure