NCT07619196已完成不适用
Observational Clinical Study for the Evaluation of Left Ventricular Filling Pressures Using Apple Watch and 12-Lead ECG Optimized by an Artificial Intelligence Algorithm
RCF@ICPS1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年7月9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
- 200
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient aged 18 years or older, capable of providing informed consent and wishing to participate in the clinical investigation
- •Patient referred outpatient for a conventional echocardiogram
- •Patient hospitalized in a medical or surgical unit, including the cardiac intensive care unit and the cardiac surgery postoperative unit, and referred for a conventional echocardiogram
- •Emergency department patient referred for a conventional echocardiogram
- •Patient who has read the information leaflet and given their written consent to participate by dating and signing the informed consent form before any procedure related to the clinical investigation
- •Patient covered by a social security scheme
排除标准
- •Patient with complex congenital heart disease
- •Heart transplant recipient
- •Patient with a history of mitral valve surgery (mechanical valve, bioprosthesis, annuloplasty)
- •Patient with a pacemaker/defibrillator
- •Patient with significant degenerative mitral annular calcification (MAC)
- •Subject related to the investigator or any other staff member directly involved in the clinical investigation
- •Patient unable to give consent, minor patient, or legally protected adult patient
结局指标
主要结局
Primary endpoint
时间窗: Day 1
Detection of elevated filling pressures in mmHG by IA-AW, compared to diagnosis by conventional transthoracic echocardiography (TTE)
次要结局
- Secondary endpoints(Day 1)
研究者
研究点 (1)
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