Functional And STructural Assesment of the Heart by Artificial Intelligence-enabled Electrocardiogram for the Management of Atrial Fibrillation
FAST-AF
1 other identifier
interventional
1,724
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 20, 2026
CompletedStudy Start
First participant enrolled
July 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
July 23, 2026
July 1, 2026
4.4 years
February 10, 2026
July 22, 2026
Conditions
Keywords
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
- +10 more secondary outcomes
Study Arms (2)
Transthoracic Echocardiography-Guided Assessment Group (TTE group)
ACTIVE COMPARATORParticipants 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.
AI-ECG-Guided Assessment Group (AI-ECG group)
EXPERIMENTALParticipants 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.
Interventions
Standard Transthoracic Echocardiography used to assess cardiac structure and function, serving as the reference standard for guiding clinical management in this study arm.
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.
Eligibility Criteria
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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Medical AIcollaborator
Study Sites (28)
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Dong-A University Hospital
Busan, South Korea
Samsung Changwon Hospital
Changwon, South Korea
Dankook University Hospital
Cheonan, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Jeonbuk National University Hospital
Jeonju, South Korea
Presbyterian Medical Center (Jesus Hospital)
Jeonju, South Korea
CHA Bundang Medical Center
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Boramae Medical Center
Seoul, South Korea
Eunpyeong St. Mary's Hospital
Seoul, South Korea
Ewha Womans University Seoul Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Hanyang University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Kyung Hee University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eue-Keun Choi, M.D. Ph.D.
Seoul National University Hospital
Central Study Contacts
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
July 29, 2026
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
December 31, 2030
Last Updated
July 23, 2026
Record last verified: 2026-07