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临床试验/NCT04921501
NCT04921501招募中不适用

Evaluation of Electrocardiographic Measurements by High Density Electrode ECG

University Hospital, Bordeaux22 个研究点 分布在 2 个国家目标入组 1,800 人开始时间: 2021年4月6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
1,800
试验地点
22
主要终点
Identification of the "amplitude" electrical criteria by HD ECG

研究概览

简要总结

Cardiac electrical activity is detected on the body surface with conventional electrocardiography involving 12 leads (ECG 12). A limitation of the current ECG technique is that recordings are obtained from only 6 independent precordial leads pairs ; which may miss cardiac potentials from spatially limited regions. More extensive sampling of the body surface may contribute to additional clinical information. The present study investigates the additional sensitivity of ECG using 128 body surface leads (High Density (HD) ECG) in measuring global or regional cardiac activity.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patient managed at the Bordeaux University Hospital for assessment of documented severe ventricular arrhythmia (VF, sudden resuscitated death) or suspected (syncope, family history of sudden death, ECG or Holter abnormality) or impaired ventricular conduction, OR
  • Patients managed for prophylactic ventricular defibrillator implantation, according to international recommendations: Heart disease with ejection fraction < 35%, heart disease with sustained ventricular tachycardia, cardiomyopathies with high rhythmic risk,
  • Women of childbearing age with effective contraception.

排除标准

  • patients under 14 years old,
  • pregnant or nursing woman.

结局指标

主要结局

Identification of the "amplitude" electrical criteria by HD ECG

时间窗: Day 0

These electrical criteria are measured in millivolt (mV)

Identification of the "cardiac time" electrical criteria by HD ECG

时间窗: Day 0

Defined by the auricular cardiac time, ventricular depolarization and repolarization time

Identification of the "duration" electrical criteria by HD ECG

时间窗: Day 0

These criteria are measured in milliseconds (ms)

Identification of "anatomical locations" electrical criteria by HD ECG

时间窗: Day 0

Defined by the position of the electrodes

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (22)

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