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

NCT07486739 | Not Yet Recruiting DMC

• 1 other identifier: FAST-AF
• Study Type: interventional
• Target: 1,724
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation; artificial intelligence; structural heart disease; electrocardiogram

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause Mortality, Stroke, CV Hospitalization, and AAD-Related SAEs

  Evaluation of the effectiveness of the strategy based on a composite endpoint comprising the following clinical events: 1. All-cause mortality; 2. Stroke or systemic thromboembolism; 3. Hospitalization due to worsening heart failure or acute coronary syndrome; 4. Serious adverse events related to antiarrhythmic drug therapy. The endpoint is defined as the time to the first occurrence of any of these components.

  up to 10 years

Secondary Outcomes (15)

• All-cause mortality

  up to 10 years

• Stroke or systemic thromboembolism

  up to 10 years

• Heart failure worsening

  up to 10 years

• Hospitalization due to acute coronary syndrome

  up to 10 years

• Serious adverse events related to antiarrhythmic drug therapy

  up to 10 years

Study Arms (2)

Transthoracic Echocardiography-Guided Assessment Group (TTE group)

ACTIVE COMPARATOR

Participants in this group will receive a standard-of-care evaluation. Cardiac function and structure will be evaluated using Transthoracic Echocardiography (TTE) regardless of ECG findings. Management (anticoagulation, rate/rhythm control) is initiated or adjusted based on TTE parameters. TTE is performed at least once annually during follow-up.

Diagnostic Test: Transthoracic Echocardiography-Guided Assessment

AI-ECG-Guided Assessment Group (AI-ECG group)

EXPERIMENTAL

Participants in this group will undergo a conditional diagnostic strategy. Cardiac function and structure are initially screened using an AI-enabled ECG. 1. Predicted Normal: TTE is withheld. Management is based on clinical evaluation and AI-ECG results. 2. Predicted Abnormal: Verification TTE is performed. Management is guided by TTE findings. Safety Note: Protocol-defined rescue TTE is permitted at the investigator's discretion for worsening symptoms or prior to procedures (cardioversion, ablation), regardless of AI-ECG results.

Diagnostic Test: Artificial intelligence-enabled electrocardiography

Interventions

Artificial intelligence-enabled electrocardiography DIAGNOSTIC_TEST

An artificial intelligence algorithm applied to standard 12-lead electrocardiography designed to predict cardiac structural or functional abnormalities. This tool guides the decision to perform or withhold downstream echocardiography.

AI-ECG-Guided Assessment Group (AI-ECG group)

Transthoracic Echocardiography-Guided Assessment DIAGNOSTIC_TEST

Standard Transthoracic Echocardiography used to assess cardiac structure and function, serving as the reference standard for guiding clinical management in this study arm.

Transthoracic Echocardiography-Guided Assessment Group (TTE group)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Aged ≥19 years at the time of enrollment and able to provide written informed consent voluntarily.

You may not qualify if:

• 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.
• Known history of structural heart disease or clinical findings suggestive of structural heart disease based on medical history and physical examination. (e.g., presence of a cardiac murmur of Levine scale grade 3 or higher on auscultation, or murmurs suggestive of moderate to severe mitral stenosis, such as an opening snap or diastolic rumbling murmur).
• Baseline electrocardiographic conduction abnormalities or significant electrocardiographic findings suggestive of clinically meaningful structural heart disease (e.g., Mobitz type II second-degree atrioventricular block, third-degree atrioventricular block, or QTc ≥480 ms).
• History of prior cardiac surgery.
• History of acute coronary syndrome or coronary revascularization within the past 90 days.
• History of intracardiac thrombosis or systemic thromboembolism within the past 90 days.
• History of transient ischemic attack, ischemic stroke, or intracranial hemorrhage within the past 90 days.
• History of ventricular tachycardia or ventricular fibrillation.
• Severe liver disease associated with coagulopathy (e.g., AST or ALT \>3× the upper limit of normal, or total bilirubin \>2× the upper limit of normal).
• Severe chronic kidney disease (stage V), requiring or imminently requiring dialysis.
• Contraindication to anticoagulation therapy.
• Pregnancy, breastfeeding, or planning pregnancy during the study period.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Medical AI: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eue-Keun Choi, M.D. Ph.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eue-Keun Choi, M.D. Ph.D.

CONTACT

82-2-2072-0688; choiek417@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 20, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

KR (1)