NCT04565652Unknown不适用
Clinical Evaluation of the LOIS Smartband in Patients Undergoing Elective ICD Implantation With Defibrillation (DFT) Threshold Testing.
Lois Medical LTD2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sensitivity of investigational device at detecting ICD shocks
研究概览
简要总结
Trial to assess the ability of a wearable to detect defibrillation from an implantable ICD
详细描述
Non-invasive, pain-free clinical evaluation of a wearable/proximity sensor designed to detect a high voltage therapeutic shock received by a patient from their Implantable Cardioverter Defibrillator (ICD) during defibrillation threshold testing (DFT), which is a routine part of the clinical procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Each patient will knowingly wear the ICD Smartband
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
- •Capable of understanding procedure and making informed consent
- •Listed for elective ICD Implant
- •Having routine DFT as part of elective ICD implantation
排除标准
- •Not indicated for ICD implant
- •Incapable of making informed consent
- •Not on stabilised anti-coagulation
结局指标
主要结局
Sensitivity of investigational device at detecting ICD shocks
时间窗: 1 year
The number of successful detection of ICD shocks using the novel ICD Smartband versus missed events
次要结局
未报告次要终点
研究者
研究点 (2)
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