NCT02700191撤回不适用
Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
Kyma Medical Technologies0 个研究点开始时间: 2016年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm.
研究概览
简要总结
Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 20-90 years old.
- •New York Heart Association (NYHA) class III-IV heart failure
- •Followed by the Congestive Heart Failure (CHF) clinic in Nazareth
- •Left ventricular ejection fraction <35%
- •Requiring treatment with >40mg/day of furosemide* orally or with repeated bolus or intravenous infusion of furosemide* (*or equivalent bumetanide or torasemide).
排除标准
- •Pregnancy
- •Subjects who have received a heart transplant.
- •Subjects who are unable or unwilling to follow the study requirements.
- •Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- •Patients with skin breakdown in areas on the chest where device and electrode placement is required
结局指标
主要结局
composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm.
时间窗: 30 days to 3 months
次要结局
未报告次要终点
研究者
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