Artificial intelligence-enabled management of atrial fibrillation

Artificial intelligence-enabled management of atrial fibrillation: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012123

Enrollment

1006

Registered

2026-06-15

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

None listed

Interventions

Medical Device, Others(Software as a Medical Device (SaMD)) : In the intervention group, guideline-directed pharmacological management of atrial fibrillation is initiated based on the left ventricular

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with atrial fibrillation and rapid ventricular response (ventricular rate = 110 bpm) confirmed on the day of outpatient visit or within 30 days prior to the visit

Exclusion criteria

Exclusion criteria: 1.Patients with left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography within the past 6 months. 2.Patients who are hemodynamically unstable and require immediate direct current cardioversion. 3.Patients requiring immediate hospitalization due to acute decompensated heart failure. 4.Patients with contraindications to pharmacological treatment for atrial fibrillation(e.g., pregnancy). 5.Patients who have experienced a clinically significant event related to structural heart disease within the past 3 months (e.g., acute myocardial infarction or hospitalization due to heart failure). 6.Patients without a 12-lead electrocardiogram in a format analyzable by the AI model. 7.Patients under 18 years of age. 8.Patients diagnosed with severe valvular heart disease(e.g., severe aortic stenosis).

Design outcomes

Primary

Measure	Time frame
The primary outcome is defined as a composite outcome consisting of the following major adverse cardiovascular events (MACE). 1. all-cause death or cardiovascular death ; 2. ischemic or hemorrhagic stroke;3. acute coronary syndrome ;4. cardiovascular hospitalization	—

Secondary

Measure	Time frame
Secondary efficacy outcome 1.all-cause death ;2.Stroke(ischemic or hemorrhagic);3.Acute myocardial infarction;4. Hospitalization due to heart failure;5. Emergency department visit or hospitalization due to cardiovascular causes ;6.Additional outpatient visits due to cardiovascular causes	—

Countries

Korea, Republic of

Contacts

Public ContactJong-il Choi

Korea University Anam Hospital

jongilchoi@korea.ac.kr+82-2-920-6710

Outcome results