NCT06552845招募中不适用
Exploratory Study of Consistency of Bi-Atrial Fibrosis Detected by Late Gadolinium Enhancement Magnetic Resonance Imaging and Low Voltage Area of Electroanatomic Mapping
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月1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
- Consistency of LGE-MRI fibrosis and EAM low-voltage area
研究概览
简要总结
This study aims to:
- Assess the consistency of LGE-MRI bi-atrial fibrosis and electroanatomical mapping of bi-atrial low voltage region
- To evaluate the electroanatomical characteristics of different types of fibrosis (dense fibrosis, patchy fibrosis, etc.) in different locations of the left and right atrium;
- To explore the correlation between preoperative and postoperative bi-atrial fibrosis and long-term recurrence in patients with atrial fibrillation.
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
- •Adult patients (≥18 years old) who are willing to participate in this study and can sign informed consent;
- •Atrial fibrillation was diagnosed and catheter ablation was proposed
排除标准
- •Left atrial thrombus or left atrial appendage thrombus;
- •Severe chronic obstructive pulmonary disease (FEV1/ FVC<70%, FEV1<50% predicted value);
- •Absolute contraindications of anticoagulation therapy;
- •Currently pregnant;
- •Contraindications for LGE-MRI (claustrophobia, pacemaker implantation, eGFR<30ml/min for renal insufficiency, severe obesity, pregnancy, gadolinium chelating agent allergy, etc.);
- •refuse to participate in the study;
- •other physical or mental incapacity to participate in the study.
结局指标
主要结局
Consistency of LGE-MRI fibrosis and EAM low-voltage area
时间窗: Baseline (at recruit time point)
Use Registration to match the corresponding spatial points of LGE-MRI and EAM。Each spatial points will contain two types of status(Fibrosis: Yes/No, Low-voltage area: Yes/No). Chi-square test will be used to assess the consistency of fibrosis and low-voltage area.
次要结局
未报告次要终点
研究者
研究点 (1)
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