Atrial Fibrillation (AF), Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
Conditions
Keywords
artificial intelligence, electrocardiography, digital biomarker, heart failure with mildly reduced ejection fraction, atrial fibrillation, catheter ablation
Brief summary
Background Artificial intelligence-enabled electrocardiography (AI-ECG) has emerged as a promising digital biomarker for detecting latent myocardial dysfunction and predicting cardiovascular risk. However, whether serial AI-derived risk estimates reflect myocardial recovery following therapeutic intervention remains unknown. Objective The DYNAMIC-AF HF Study aims to evaluate longitudinal changes in AI-ECG-derived heart failure (HF) risk after catheter ablation in patients with atrial fibrillation (AF) and heart failure with mildly reduced ejection fraction (HFmrEF), and to determine their association with conventional markers of reverse remodeling. Methods The DYNAMIC-AF HF Study is a prospective multicenter observational cohort study enrolling 1,000 patients with symptomatic AF and HFmrEF undergoing first-time catheter ablation. Eligible participants must have a left ventricular ejection fraction of 41-49% and at least one predefined HF-related feature suggestive of latent myocardial dysfunction. Serial 12-lead electrocardiograms, echocardiography, biomarker assessments, and clinical follow-up will be performed at baseline and at 3, 6, and 12 months. AI-based ECG analysis will generate continuous HF-risk scores, enabling construction of longitudinal AI-derived HF risk trajectories. The primary endpoint is the change in AI-derived HF risk from baseline to 12 months. Secondary endpoints include changes in left ventricular ejection fraction, global longitudinal strain, N-terminal pro-B-type natriuretic peptide levels, AF recurrence, HF hospitalization, and mortality. Conclusions This study will evaluate whether serial AI-ECG assessment can serve as a dynamic digital biomarker of myocardial recovery following AF ablation and support future AI-enabled monitoring and clinical decision-support strategies in cardiovascular care.
Interventions
None listed
Sponsors
Ewha Womans University Mokdong Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years * Symptomatic paroxysmal or persistent atrial fibrillation * Scheduled for first-time catheter ablation * Left ventricular ejection fraction between 41% and 49% measured by transthoracic echocardiography within 3 months before ablation * At least one analyzable sinus rhythm 12-lead electrocardiogram before ablation * At least one latent heart failure substrate feature: * Elevated NT-proBNP * Increased left atrial volume index (\>34 mL/m²) * Average E/e' ≥14 * Reduced global longitudinal strain * Mild pulmonary hypertension * Exertional intolerance suggestive of early heart failure * Ability to provide written informed consent
Exclusion criteria
* Left ventricular ejection fraction ≤40% * Previous atrial fibrillation catheter ablation * Significant valvular heart disease requiring intervention * Hypertrophic or infiltrative cardiomyopathy * Acute coronary syndrome, coronary revascularization, or myocarditis within 3 months * Severe renal dysfunction requiring dialysis * Active malignancy with life expectancy \<1 year * Inadequate electrocardiographic or echocardiographic image quality * Pregnancy * Inability or unwillingness to provide written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in AI-derived Heart Failure Risk Score | Baseline to 12 months after catheter ablation | Difference in the AI-enabled electrocardiography (AI-ECG)-derived heart failure risk score (continuous probability ranging from 0 to 1) between baseline and 12 months after first-time catheter ablation. Higher values indicate a greater predicted probability of underlying heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction | Baseline to 12 months after catheter ablation | Absolute change in left ventricular ejection fraction measured by transthoracic echocardiography. |
| Change in Global Longitudinal Strain | Baseline to 12 months after catheter ablation | Change in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography. |
| Change in Left Atrial Volume Index | Baseline to 12 months after catheter ablation | Change in left atrial volume index measured by transthoracic echocardiography. |
| Change in E/e' Ratio | Baseline to 12 months after catheter ablation | Change in echocardiographic estimate of left ventricular filling pressure. |
| Change in NT-proBNP | Baseline to 12 months after catheter ablation | Change in serum N-terminal pro-B-type natriuretic peptide concentration. |
| Atrial Fibrillation Recurrence | Up to 12 months after catheter ablation | Documented atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds after the 3-month blanking period. |
| Heart Failure Hospitalization | Up to 12 months after catheter ablation | Hospitalization primarily related to worsening heart failure requiring medical treatment. |
| Cardiovascular Hospitalization | Up to 12 months after catheter ablation | Hospitalization due to cardiovascular causes including arrhythmia, heart failure, ischemic events, or procedure-related complications. |
| All-cause Mortality | Up to 12 months after catheter ablation | Death from any cause during study follow-up. |
Countries
South Korea
Contacts
CONTACTYeji Kim, PhD
Outcome results
None listed