A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- The 'CardioGard Cannula' Gaseous emboli capturing ability
研究概览
简要总结
This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.
详细描述
Patients referred for CPB procedure will be offered to participate in the study. Patients will be asked to sign an informed consent form (ICF), prior to performing any study related procedures.
The point of enrollment is the time at which a patient signs and dates the ICF. Following enrollment, the patient will undergo screening evaluation (including Neurological assessment) to determine eligibility. Screening failures will be identified on a screening log. Patients who are found to meet all inclusion criteria and none of the exclusion criteria will compose the evaluable cohort of the study. Screening failure subjects will not be counted as part of the target patient sample size nor will they be included in the analysis.
Patients in the randomized phase will have surgery with the CardioGard Cannula or comparator cannulae and will remain blinded to their group assignment through the 30 days follow-up evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass which is expected to last up to 6 hours.
- •Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG).
- •The patient is >50 and <85 years of age.
- •The patient's body weight is compatible with blood net flow of 4 - 5 [l/min].
- •Patient with left ventricular ejection fraction >30% as assessed by either echocardiography, angiography or by radio nuclear assessment (MUGA)
- •The patient is willing to participate as evidenced by signing the written informed consent.
- •Male or non-pregnant female patient (Note: Females of child bearing potential must have a negative pregnancy test)
排除标准
- •Patient with abnormal clotting mechanism: PT 60%, PTT>2 the normal.
- •Patient with an aortic trauma.
- •Patient contraindicated for open heart surgery under bypass machine.
- •Patient undergoing a re-do procedure.
- •Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy)
- •Patient with pathologies which affect his/her neurological condition.
- •Patient in whom emergency operation is required.
- •Patient with a known allergy to Heparin
- •Patient with major co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study, including but not limited to:
- •previous stroke
- •critical preoperative state
- •poor ventricular function
- •severe pulmonary hypertension [19]
- •Atheroembolism
- •history of cardiac failure [20]
- •Current use of drugs that might result in high surgical risk or significant postoperative complication.
- •Psychological instability, inappropriate attitude or motivation.
- •Patients with life threatening debilitating disease other than cardiac.
- •Subjects currently enrolled in another investigational device or drug trial that has not completed the primary end point or that clinically interferes with the current study endpoints.
研究组 & 干预措施
CardioGard group
Patients in whom the CardioGard Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in two points: 1. The aortic vent.
- The suction cannula of the 'Cardiogard cannula'.
干预措施: CardioGard Cannula (Device)
Control group
Patients in whom a 22Fr curved Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in the aortic vent alone.
干预措施: 22Fr curved Cannula (Device)
结局指标
主要结局
The 'CardioGard Cannula' Gaseous emboli capturing ability
时间窗: 36 months
The gaseous emboli capturing ability of the cardiogard cannula will be evaluated using a bubbles counter. .
次要结局
- The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula(36 months)
- The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.(36 months)
研究者
Gil Bolotin MD
Professor
Rambam Health Care Campus