A Prospective,Open,Multicentre,RCT to Assess the Safety & Efficacy of Navigator v Conventional Care in Post-op Cardiac Surgery Patients Undergoing CABG &/or Heart Valve Repair/Replacement Utilising Heart Lung Perfusion Pump(The NAV-1 Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 7
- 主要终点
- Average distance to central point of the target cardiovascular zone while connected to the device
研究概览
简要总结
A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided Circulatory Management System versus conventional care in post-operative cardiac surgery patients. The purpose of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by the Navigator guided circulatory management system provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an Intensive Care Unit setting.
详细描述
Protocol No. AP2006-01
Study title: A Prospective, Open, Randomised, Multicentre, Controlled Group Study to Assess the Safety and Efficacy of Navigator versus Conventional Care in Postoperative Cardiac Surgery Patients Undergoing Coronary Bypass Grafting and or Heart Valve Repair or Replacement Utilizing Heart Lung Perfusion Pump.
Acronym: NAV 1
Type of study: Device Trial
Sponsor: Applied Physiology Pty Ltd
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female aged 18 years or older
- •Undergoing elective cardiac surgery where surgery involves the use of a heart-lung perfusion pump
- •Will have an arterial line and Swan Ganz catheter in situ
- •Require invasive measurement of Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP)
- •Are able and willing to provide written informed consent to participate in the study
排除标准
- •Women who are lactating or pregnant
- •Require Extracorporeal Membrane Oxygenation
- •Present at baseline screening or immediately prior to randomisation in the ICU with atrial fibrillation (irregular supraventricular rhythm, not due to ectopic complexes with an absence of discrete P-waves lasting more than 10 minutes documented and confirmed with an ECG)
- •Intra-operative surgical treatment for atrial fibrillation
- •Surgery for left atrial reduction
- •Patients with left ventricular assist devices
- •Patients with permanent pacemakers in situ
- •Deemed by the investigator to be uncooperative or unsuitable for inclusion into this trial
- •Have a medical condition that in the opinion of the investigator would jeopardise the patient's safety by participating in this trial
- •Current participation in another drug or device study
研究组 & 干预措施
1
Device , Navigator used for guiding haemodynamic care
干预措施: Navigator (Device)
2
Conventional care
干预措施: Conventional care (Other)
结局指标
主要结局
Average distance to central point of the target cardiovascular zone while connected to the device
时间窗: Time connected to Navigator device
次要结局
- Percentage time in the target cardiovascular zone while connected to device(Time connected to Navigator device)
- Clinically significant AF while connected to device(Time connected to Navigator device)
- Multiple organ function (SOFA score)(From connection to Navigator device to hospital discharge)
- Device-related adverse events and device failures(Time connected to Navigator device)