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临床试验/NCT07708818
NCT07708818尚未招募不适用

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

Ewha Womans University Mokdong Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2027年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
1
主要终点
Change in AI-derived Heart Failure Risk Score

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

AF-HFmrEF Cohort

结局指标

主要结局

Change in AI-derived Heart Failure Risk Score

时间窗: 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.

次要结局

  • Change in E/e' Ratio(Baseline to 12 months after catheter ablation)
  • Change in Left Ventricular Ejection Fraction(Baseline to 12 months after catheter ablation)
  • Change in Global Longitudinal Strain(Baseline to 12 months after catheter ablation)
  • Change in Left Atrial Volume Index(Baseline to 12 months after catheter ablation)
  • Change in NT-proBNP(Baseline to 12 months after catheter ablation)
  • Atrial Fibrillation Recurrence(Up to 12 months after catheter ablation)
  • Heart Failure Hospitalization(Up to 12 months after catheter ablation)
  • Cardiovascular Hospitalization(Up to 12 months after catheter ablation)
  • All-cause Mortality(Up to 12 months after catheter ablation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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