Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

The objective of this study is to evaluate whether an AI-ECG based screening strategy for detecting cardiac functional and structural abnormalities preserves clinical effectiveness and safety, compared with a conventional strategy of routine echocardiography in patients with AF, thereby demonstrating the non-inferiority of AI-ECG guided care.

Eligibility criteria

Qualifiers

AF documented by electrocardiography within the past 12 months

AF documented on a 12-lead electrocardiogram or recorded for ≥30 seconds on a single-lead or multi-lead electrocardiogram.

Patients for whom an initial or repeat transthoracic echocardiographic evaluation is clinically indicated.

A CHA₂DS₂-VA score of ≥2.

Disqualifiers

Transthoracic echocardiography performed within the past 6 months.

Ventricular rate ≥110 beats per minute during atrial fibrillation.

Atrial fibrillation due to a reversible cause.

New York Heart Association (NYHA) functional class IV or European Heart Rhythm Association (EHRA) class IV symptoms.

Trial design

Treatments tested in this trial

  • Artificial intelligence-enabled electrocardiography
  • Transthoracic Echocardiography-Guided Assessment

Treatment groups

1,724 Participants
are divided into 2 treatment groups

Sponsors and collaborators