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临床试验/NCT05873920
NCT05873920招募中不适用

Impact of Individual Atrial Arrhythmia Substrate on the Outcome Following Radiofrequency-Guided Catheter Ablation for Atrial Fibrillation in Patients With Diabetes Mellitus

Heart and Diabetes Center North-Rhine Westfalia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
atrial fibrillation recurrence

研究概览

简要总结

Single center prospective study to analyze the impact of diabetes mellitus on patients' outcome following radiofrequency-guided catheter ablation for atrial fibrillation.

详细描述

A total number of 50 patients with diabetes mellitus will undergo radiofrequency-guided catheter ablation for atrial fibrillation. Pre-procedural cardiac MRI will be performed with late-gadolinium enhancement to visualize the individual amount and distribution of fibrosis in the right and left atrium. The relationship between diabetes mellitus and individual atrial arrhythmia substrates as well as patients' outcome following catheter ablation will be analyzed.

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
否

入选标准

  • •Patients undergoing their 1st radiofrequency-guided catheter ablation for atrial fibrillation
  • •Diabetes mellitus
  • •Able to understand and willing to sign the Informed Consent Form.
  • •Age ≥18 years.

排除标准

  • •Contraindication for DE-MRI with a full dose of gadolinium-based contrast agent.
  • •Previous left atrial ablation or surgical procedure
  • •Women currently pregnant, breastfeeding, or of childbearing age not currently taking or not willing to use a reliable form of contraception
  • •Mental or physical inability to take part in the study
  • •Morbid obesity (BMI > 35), or inability to be placed in MRI due to body mass.

结局指标

主要结局

atrial fibrillation recurrence

时间窗: 12 months

atrial fibrillation recurrence following catheter ablation

次要结局

未报告次要终点

研究者

发起方
Heart and Diabetes Center North-Rhine Westfalia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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