An AI-ECG-Based Approach for Dynamic Assessment of Heart Failure Risk and Myocardial Recovery Following Atrial Fibrillation Ablation
16 juillet 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Type d'étude
Observationnel
Inscription (Estimé)
1000
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yeji Kim, PhD
- Numéro de téléphone: +82-10-8680-9542
- E-mail: lexie6169@gmail.com
Lieux d'étude
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Seoul, Corée du Sud, 07804
- Ewha Womans University Mokdong Hospital
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Contact:
- Yeji Kim, PhD
- Numéro de téléphone: +82-10-8680-9542
- E-mail: lexie6169@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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AF-HFmrEF Cohort
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in AI-derived Heart Failure Risk Score
Délai: Baseline to 12 months after catheter ablation
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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.
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Baseline to 12 months after catheter ablation
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Left Ventricular Ejection Fraction
Délai: Baseline to 12 months after catheter ablation
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Absolute change in left ventricular ejection fraction measured by transthoracic echocardiography.
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Baseline to 12 months after catheter ablation
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Change in Global Longitudinal Strain
Délai: Baseline to 12 months after catheter ablation
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Change in left ventricular global longitudinal strain assessed by speckle-tracking echocardiography.
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Baseline to 12 months after catheter ablation
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Change in Left Atrial Volume Index
Délai: Baseline to 12 months after catheter ablation
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Change in left atrial volume index measured by transthoracic echocardiography.
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Baseline to 12 months after catheter ablation
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Change in E/e' Ratio
Délai: Baseline to 12 months after catheter ablation
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Change in echocardiographic estimate of left ventricular filling pressure.
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Baseline to 12 months after catheter ablation
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Change in NT-proBNP
Délai: Baseline to 12 months after catheter ablation
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Change in serum N-terminal pro-B-type natriuretic peptide concentration.
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Baseline to 12 months after catheter ablation
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Atrial Fibrillation Recurrence
Délai: Up to 12 months after catheter ablation
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Documented atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds after the 3-month blanking period.
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Up to 12 months after catheter ablation
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Heart Failure Hospitalization
Délai: Up to 12 months after catheter ablation
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Hospitalization primarily related to worsening heart failure requiring medical treatment.
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Up to 12 months after catheter ablation
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Cardiovascular Hospitalization
Délai: Up to 12 months after catheter ablation
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Hospitalization due to cardiovascular causes including arrhythmia, heart failure, ischemic events, or procedure-related complications.
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Up to 12 months after catheter ablation
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All-cause Mortality
Délai: Up to 12 months after catheter ablation
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Death from any cause during study follow-up.
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Up to 12 months after catheter ablation
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Marrouche NF, Brachmann J, Andresen D, Siebels J, Boersma L, Jordaens L, Merkely B, Pokushalov E, Sanders P, Proff J, Schunkert H, Christ H, Vogt J, Bansch D; CASTLE-AF Investigators. Catheter Ablation for Atrial Fibrillation with Heart Failure. N Engl J Med. 2018 Feb 1;378(5):417-427. doi: 10.1056/NEJMoa1707855.
- Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW; ACC/AHA Joint Committee Members. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1.
- Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.
- Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR; Peer Review Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.
- Kwon JM, Kim KH, Eisen HJ, Cho Y, Jeon KH, Lee SY, Park J, Oh BH. Artificial intelligence assessment for early detection of heart failure with preserved ejection fraction based on electrocardiographic features. Eur Heart J Digit Health. 2020 Dec 10;2(1):106-116. doi: 10.1093/ehjdh/ztaa015. eCollection 2021 Mar.
- Kwon JM, Kim KH, Jeon KH, Kim HM, Kim MJ, Lim SM, Song PS, Park J, Choi RK, Oh BH. Development and Validation of Deep-Learning Algorithm for Electrocardiography-Based Heart Failure Identification. Korean Circ J. 2019 Jul;49(7):629-639. doi: 10.4070/kcj.2018.0446. Epub 2019 Mar 21.
- Bozkurt B, Coats AJ, Tsutsui H, Abdelhamid M, Adamopoulos S, Albert N, Anker SD, Atherton J, Bohm M, Butler J, Drazner MH, Felker GM, Filippatos G, Fonarow GC, Fiuzat M, Gomez-Mesa JE, Heidenreich P, Imamura T, Januzzi J, Jankowska EA, Khazanie P, Kinugawa K, Lam CSP, Matsue Y, Metra M, Ohtani T, Francesco Piepoli M, Ponikowski P, Rosano GMC, Sakata Y, SeferoviC P, Starling RC, Teerlink JR, Vardeny O, Yamamoto K, Yancy C, Zhang J, Zieroth S. Universal Definition and Classification of Heart Failure: A Report of the Heart Failure Society of America, Heart Failure Association of the European Society of Cardiology, Japanese Heart Failure Society and Writing Committee of the Universal Definition of Heart Failure. J Card Fail. 2021 Apr;27(4):387-413. doi: 10.1016/j.cardfail.2021.01.022. Epub 2021 Mar 1.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 janvier 2027
Achèvement primaire (Estimé)
31 décembre 2028
Achèvement de l'étude (Estimé)
31 décembre 2029
Dates d'inscription aux études
Première soumission
11 juillet 2026
Première soumission répondant aux critères de contrôle qualité
11 juillet 2026
Première publication (Réel)
16 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- DYNAMIC-AF HF
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .