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NCT Number: NCT07708818

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

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.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF) Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in AI-derived Heart Failure Risk Score

    Time frame: 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 outcomes

  1. Change in Left Ventricular Ejection Fraction

    Time frame: Baseline to 12 months after catheter ablation

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

  2. Change in Global Longitudinal Strain

    Time frame: Baseline to 12 months after catheter ablation

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

  3. Change in Left Atrial Volume Index

    Time frame: Baseline to 12 months after catheter ablation

    Change in left atrial volume index measured by transthoracic echocardiography.

  4. Change in E/e' Ratio

    Time frame: Baseline to 12 months after catheter ablation

    Change in echocardiographic estimate of left ventricular filling pressure.

  5. Change in NT-proBNP

    Time frame: Baseline to 12 months after catheter ablation

    Change in serum N-terminal pro-B-type natriuretic peptide concentration.

  6. Atrial Fibrillation Recurrence

    Time frame: 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.

  7. Heart Failure Hospitalization

    Time frame: Up to 12 months after catheter ablation

    Hospitalization primarily related to worsening heart failure requiring medical treatment.

  8. Cardiovascular Hospitalization

    Time frame: Up to 12 months after catheter ablation

    Hospitalization due to cardiovascular causes including arrhythmia, heart failure, ischemic events, or procedure-related complications.

  9. All-cause Mortality

    Time frame: Up to 12 months after catheter ablation

    Death from any cause during study follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Yeji Kim, PhD

CONTACT

[email protected]

+82-10-8680-9542

Sponsors and collaborators

Lead sponsor

Ewha Womans University Mokdong Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Jul 16, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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