An AI-ECG-Based Approach for Dynamic Assessment of Heart Failure Risk and Myocardial Recovery Following Atrial Fibrillation Ablation
16 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Observacional
Inscrição (Estimado)
1000
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Yeji Kim, PhD
- Número de telefone: +82-10-8680-9542
- E-mail: lexie6169@gmail.com
Locais de estudo
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Seoul, Coréia do Sul, 07804
- Ewha Womans University Mokdong Hospital
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Contato:
- Yeji Kim, PhD
- Número de telefone: +82-10-8680-9542
- E-mail: lexie6169@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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AF-HFmrEF Cohort
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in AI-derived Heart Failure Risk Score
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in Left Ventricular Ejection Fraction
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de janeiro de 2027
Conclusão Primária (Estimado)
31 de dezembro de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
11 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de julho de 2026
Primeira postagem (Real)
16 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
16 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DYNAMIC-AF HF
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .