Electrophysiology of Fetal Arrhythmia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Rhythm assessment
研究概览
简要总结
Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The proposed study will allow the investigators to evaluate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm.
详细描述
Purpose
Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The purpose of the proposed study is to utilize fMCG, the magnetic analog of fetal ECG, to characterize the heart rate and rhythm patterns of fetuses with fetal arrhythmia or at risk of fetal arrhythmia. The study is not intended to be a pivotal study. The subject device is already cleared for clinical use for recording of fetal rhythm; however, FDA has determined that an IDE is required for the proposed study. The study is expected to last approximately 10 years
The Tristan 624 is housed within the magnetically shielded room in the Biomagnetism Laboratory located within the Wisconsin Institutes for Medical Research on the University of Wisconsin-Madison campus.
Protocol
Facilities
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •uncomplicated pregnancy at gestational age >12 weeks
- •pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age >15 weeks
排除标准
- •uncomplicated pregnancy <12 weeks gestation
- •pregnancy complicated by abnormal fetal heart rate or rhythm or risk of abnormal fetal heart rate or rhythm at gestational age <15 weeks
结局指标
主要结局
Rhythm assessment
时间窗: after 15 weeks gestation
fetal MCG rhythm assessment
次要结局
未报告次要终点