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

16. juli 2026 oppdatert av: 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.

Studieoversikt

Studietype

Observasjonsmessig

Registrering (Antatt)

1000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

      • Seoul, Sør -Korea, 07804
        • Ewha Womans University Mokdong Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
AF-HFmrEF Cohort

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in AI-derived Heart Failure Risk Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Left Ventricular Ejection Fraction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 12 months after catheter ablation
Death from any cause during study follow-up.
Up to 12 months after catheter ablation

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2029

Datoer for studieregistrering

Først innsendt

11. juli 2026

Først innsendt som oppfylte QC-kriteriene

11. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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