NCT03714126已完成不适用
A Non-Intervantional Study to Create a Patient Recordings and Clinical Database Using the Cordio System
Cordio Medical1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2019年3月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of CHF patients with and without acute lung accumulation. in R&D Database
研究概览
简要总结
This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Patients undergoing hemodialysis every 5-10 days in order to balance their volume overload.
- •Class C Heart Failure patient with reduced EF CHF (EF<40%) and NYHA 2-
- •Patients with dyspnea clinically related to pulmonary congestion
- •Patient with more than 3 months HF disease duration.
- •The patient is willing to participate as evidenced by signing the written informed consent.
- •Male or non-pregnant female patient
排除标准
- •Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
- •Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
- •Patients likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit or baseline functional capacity of NYHA
- •Patients with evidence of active Infection.
- •Patient with severe alcohol or drug use.
- •Psychological instability, inappropriate attitude or motivation.
- •Patient with life threatening debilitating disease other than cardiac.
- •Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
结局指标
主要结局
Number of CHF patients with and without acute lung accumulation. in R&D Database
时间窗: throughout study, upto 60 days per patient
The objective of the study is to create a recordings database of CHF patients with and without acute lung accumulation.
次要结局
未报告次要终点
研究者
研究点 (1)
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