Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the HL 40 Heart Lung Machine and the Temperature Probes in Patients Undergoing Cardiac / Thoracic / Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- Safety Endpoint
研究概览
简要总结
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing cardiac / thoracic / vascular surgery.
详细描述
In this study, patients who are connected to the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric and undergo a cardiac / thoracic / vascular surgery will be observed. This includes neonates, infants, adolescents and adults regardless of age and underlying health condition. It also includes elective, urgent and emergent surgeries.
Data will be collected for each participant according to the study schedule and standard routine clinical practice at the enrolling centers. There will be no additional visits, nor procedures pertaining to the study itself for subjects who participate in the study.
Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected.
The period of data collection for each patient will be only the index procedure. The index procedure is defined as the investigator's planned initial procedure in which the patient is connected to the HL 40 and the Temperature Probes. The index procedure starts with the cannulation of the patient for the index procedure and ends with the de-cannulation of the patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Patient Informed Consent (including emergency approach)
- •All patients who are connected to extracorporeal circulation using the index devices.
排除标准
- •Pregnancy
- •Current participation or planned participation in a concurrent drug or interventional medical device study
结局指标
主要结局
Safety Endpoint
时间窗: Only during the index procedure, no FU.
The rate of index device(s) related Adverse Events during the index procedure.
Performance Endpoint
时间窗: Only during the index procedure, no FU.
The rate of cases performed by the index devices during the index procedure without any failure and / or malfunction related to the index device(s).
次要结局
未报告次要终点