MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,097
- 试验地点
- 1
- 主要终点
- Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
研究概览
简要总结
In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch.
详细描述
The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30 minutes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent, i.e., the subject must be able to understand and sign the Patient Information and Consent Form.
- •Group 1: Patients that have an indication for an echocardiographic assessment.
- •Group 2: Patients that are scheduled for a non-cardiac surgery
排除标准
- •Subjects has implanted cardioverter defibrillator
- •Subject is pregnant
- •Subject is breastfeeding
- •Subject has compromised skin in the location where the LynxPatch is intended to be positioned
结局指标
主要结局
Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.
时间窗: 30 minutes per individual
Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.
次要结局
- Accuracy of the LynxPatch device predictions of an adverse perioperative outcome(30 days per individual)
- Usability of the LynxPatch device(30 minutes per individual)
- Rate of LynxPatch-related safety incidents(30 minutes per individual)