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临床试验/NCT07651046
NCT07651046撤回不适用

Using CCTA to Assess Heart Function and Predict AF Recurrence After Ablation

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
600
试验地点
1
主要终点
Recurrence of atrial arrhythmia after ablation

研究概览

简要总结

This study aims to evaluate whether structural and functional parameters of the left atrium and left ventricle, measured by cardiac computed tomography angiography (CCTA), can predict clinical outcomes after radiofrequency ablation in patients with atrial fibrillation (AF). Atrial fibrillation is a common heart rhythm disorder, and while catheter ablation is an effective treatment, some patients experience recurrence. Current predictive tools have limitations. This prospective observational study will enroll patients with AF scheduled for first-time radiofrequency ablation. All participants will undergo CCTA before the ablation procedure to assess left atrial and left ventricular volumes, ejection fraction, and strain parameters. After ablation, patients will be followed for 12 months to monitor recurrence of atrial arrhythmias. The primary outcome is the recurrence of atrial fibrillation or atrial tachycardia lasting more than 30 seconds after a 3-month blanking period. The study will determine whether CCTA-derived parameters improve risk stratification for post-ablation recurrence. Findings may help identify patients who are more likely to benefit from ablation or who may need additional therapy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Meet the indications for radiofrequency ablation recommended by relevant atrial fibrillation diagnosis and treatment guidelines
  • Age ≥ 18 years
  • First-time radiofrequency ablation

排除标准

  • history of cardiac ablation
  • structural heart diseases, such as cardiomyopathy, valvular disease, heart failure, and acute myocardial infarction
  • severe renal failure (estimated glomerular filtration rate <30 ml/m2)
  • left ventricular (LV) ejection fraction <30%
  • poor image quality inadequate for assessment

结局指标

主要结局

Recurrence of atrial arrhythmia after ablation

时间窗: 12 months after ablation (following the initial 3-month blanking period)

Recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia lasting 30 seconds or longer, documented by electrocardiogram (ECG) or Holter monitoring, after a 3-month blanking period following radiofrequency ablation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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