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.

The development of artificial intelligence system guided patient selection for atrial fibrillation catheter ablation: randomized clinical trial (AI-PAFA Trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008141

Enrollment

1000

Registered

2023-01-17

Start date

2021-10-07

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : 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

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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;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);Clinical recurrence rate - Defined as AF or atrial tachycardia lasting over 30 seconds after 3 months of procedure.	—

Measure

Time frame

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;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);Clinical recurrence rate - Defined as AF or atrial tachycardia lasting over 30 seconds after 3 months of procedure.

—

Secondary

Measure	Time frame
Comparison of procedure time, ablation time and hospitalization period;Anti-arrhythmic drug or anticoagulation therapy related complication rate;Re-hospitalization rate and number of electrical cardioverson after the procedure;Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure	—

Countries

Korea, Republic of

Contacts

Public ContactSuah Lee

Yonsei University Health System, Severance Hospital

suah98@yuhs.ac+82-2-2228-8528

Outcome results