An AI-ECG-Based Approach for Dynamic Assessment of Heart Failure Risk and Myocardial Recovery Following Atrial Fibrillation Ablation
2026年7月16日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
観察的
入学 (推定)
1000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Yeji Kim, PhD
- 電話番号：+82-10-8680-9542
- メール：lexie6169@gmail.com
研究場所
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Seoul、韓国、07804
- Ewha Womans University Mokdong Hospital
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コンタクト：
- Yeji Kim, PhD
- 電話番号：+82-10-8680-9542
- メール：lexie6169@gmail.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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AF-HFmrEF Cohort
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in AI-derived Heart Failure Risk Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Left Ventricular Ejection Fraction
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- 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.
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- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2027年1月1日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2029年12月31日
試験登録日
最初に提出
2026年7月11日
QC基準を満たした最初の提出物
2026年7月11日
最初の投稿 (実際)
2026年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月20日
QC基準を満たした最後の更新が送信されました
2026年7月16日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- DYNAMIC-AF HF
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
IPD プランの説明
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.
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いいえ
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