Synchronized Cardiac Assist for Cardiogenic Shock. The SynCor Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xenios AG
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of Participants With Device and Procedure Related Serious Adverse Events
研究概览
简要总结
The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous intervention procedures in catheterization lab.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in cardiogenic shock in the setting of acute myocardial infarction
- •Patients undergoing high risk coronary revascularization procedures (e.g., multi-vessel disease, left main, or last patent conduit interventions) in the catheterization lab.
- •Cardiogenic shock is defined as
- •Systolic blood pressure < 90 mmHg for at least 30 min or
- •Inotropes are needed to maintain blood pressure > 90 mmHg or
- •Clinical signs of heart insufficiency with pulmonary congestion or
- •Signs of end organ hypoperfusion with at least one of the following criteria:
- •Altered mental status
- •cold, damp skin or extremities
- •oliguria (≤ 30 mL/h)
- •serum lactate > 2.0 mmol/L
- •Written consent of the patient or the legal caregiver
排除标准
- •Age > 85 years
- •Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 10 min
- •Coma with fixed pupils not induced by drugs;
- •Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
- •Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
- •Fever (Body temperature > 38.0 °C) or other evidence of sepsis
- •Onset of cardiogenic shock > 6 h before enrollment;
- •Lactate > 22 mmol/L;
- •Massive pulmonary embolism;
- •Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
- •Previous known aortic regurgitation greater than grade II
- •Contra-indications for anticoagulation
- •Severe hemolysis of any cause
- •Patient is participating in an investigational drug or device study trial that has not reached the primary endpoint or that interferes with the current study endpoints.
结局指标
主要结局
Number of Participants With Device and Procedure Related Serious Adverse Events
时间窗: 30 days
Acute safety defined as rates of device and procedure related serious adverse events up to 30 days post-intervention.
Number of Participants Treated With Technical Success of the Device
时间窗: 24 hours
Technical success (defined as the ability to successfully deliver the i-COR® SYNCHRONIZED CARDIAC ASSIST device without serious adverse events).
Number of Participants With Device Performance Success
时间窗: 7 days
Device performance success (defined as the ability to establish synchronized pulsatile cardiac assist, enhance cardiac function and improve tissue oxygenation) assessed immediately post-procedure (acute) and serially as the device remains in place and provides cardiac support over time in each patient.
次要结局
未报告次要终点