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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.

Not Applicable
Recruiting
Conditions
Diseases of the circulatory system
Registration Number
KCT0008141
Lead Sponsor
Yonsei University Health System, Severance Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1000
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

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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
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