An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 44
- 主要终点
- Heart Failure Events (HFEs)
研究概览
简要总结
Study Design:
This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.
详细描述
Two periods:
Run-In period will be a period in which patients will submit daily recordings, baseline creation
Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 22 or greater
- •Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]
- •At least one of the following:
- •One ADHF hospitalization in the last 12 months
- •One unplanned IV/SC diuretic administration in the last 6 months
- •Two unplanned IV/SC diuretic administrations in the last 12 months
- •NTProBNP >500 pg/ml
- •Clinically stable HF according to investigator discretion
- •Willing to participate as evidenced by signing the written informed consent.
排除标准
- •Unable to comply with daily use of the App,
- •Has had a major cardiovascular event within 3 months prior to enrolment.
- •Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
- •Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.
- •Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
- •Was treated for a significant COPD
结局指标
主要结局
Heart Failure Events (HFEs)
时间窗: EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient
Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. Having no Heart Failure Event (HFE) during the entire CORE period
次要结局
未报告次要终点