An AI-ECG-Based Approach for Dynamic Assessment of Heart Failure Risk and Myocardial Recovery Following Atrial Fibrillation Ablation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEwha Womans University Mokdong Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Left ventricular ejection fraction ≤40%

Previous atrial fibrillation catheter ablation

Significant valvular heart disease requiring intervention

Hypertrophic or infiltrative cardiomyopathy

Trial population

The study population consists of adults with symptomatic paroxysmal or persistent atrial fibrillation and heart failure with mildly reduced ejection fraction (left ventricular ejection fraction 41-49%) who are scheduled to undergo first-time catheter ablation. Participants are prospectively enrolled at five tertiary referral centers and are additionally required to have at least one feature suggestive of latent heart failure substrate, including elevated natriuretic peptide levels, impaired global longitudinal strain, increased left atrial volume index, elevated E/e' ratio, or exertional intolerance. All participants undergo standardized longitudinal follow-up with serial 12-lead electrocardiography, echocardiography, biomarker assessment, and clinical evaluation for 12 months after catheter ablation.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: AF-HFmrEF Cohort

Trial outcomes

Primary outcomes

1

Change in AI-derived Heart Failure Risk Score

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.

Time frame
Baseline to 12 months after catheter ablation

Secondary outcomes

1

Change in Left Ventricular Ejection Fraction

Absolute change in left ventricular ejection fraction measured by transthoracic echocardiography.

Time frame
Baseline to 12 months after catheter ablation
2

Change in Global Longitudinal Strain

Change in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography.

Time frame
Baseline to 12 months after catheter ablation
3

Change in Left Atrial Volume Index

Change in left atrial volume index measured by transthoracic echocardiography.

Time frame
Baseline to 12 months after catheter ablation
4

Change in E/e' Ratio

Change in echocardiographic estimate of left ventricular filling pressure.

Time frame
Baseline to 12 months after catheter ablation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: