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

July 16, 2026 updated by: Ewha Womans University Mokdong Hospital

DYNAMIC-AF HF Study: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea, 07804
        • Ewha Womans University Mokdong Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
AF-HFmrEF Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 months after catheter ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 months after catheter ablation
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.
Baseline to 12 months after catheter ablation
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.
Baseline to 12 months after catheter ablation
Change in E/e' Ratio
Time Frame: Baseline to 12 months after catheter ablation
Change in echocardiographic estimate of left ventricular filling pressure.
Baseline to 12 months after catheter ablation
Change in NT-proBNP
Time Frame: Baseline to 12 months after catheter ablation
Change in serum N-terminal pro-B-type natriuretic peptide concentration.
Baseline to 12 months after catheter ablation
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.
Up to 12 months after catheter ablation
Heart Failure Hospitalization
Time Frame: Up to 12 months after catheter ablation
Hospitalization primarily related to worsening heart failure requiring medical treatment.
Up to 12 months after catheter ablation
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.
Up to 12 months after catheter ablation
All-cause Mortality
Time Frame: Up to 12 months after catheter ablation
Death from any cause during study follow-up.
Up to 12 months after catheter ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 11, 2026

First Submitted That Met QC Criteria

July 11, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYNAMIC-AF HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision regarding sharing de-identified individual participant data has not yet been finalized. Data sharing will be considered after completion of the study, publication of the primary results, and in accordance with institutional policies, participant consent, and applicable ethical and regulatory requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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