Performance of the CARDIOGARD Cannula (GECG)
A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的: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. 2. The suction cannula of the 'Cardiogard cannula'. |
CardioGard Cannula is a specially designed arterial (aortic) cannula for use in cardiac surgery for the purpose of removal of gaseous and solid embolic material emanating during the CPB procedure. The CardioGard cannula is a double lumen cannula where the primary lumen provides blood from the heart-lung machine similar to ordinary cannulas and the secondary lumen performs suction of blood and embolic matter away from the aortic arch and back to the cardiopulmonary bypass machine for filtration. |
有源比较器: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.
|
arterial cannula for use in cardiac surgery
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The 'CardioGard Cannula' Gaseous emboli capturing ability
大体时间:36 months
|
The gaseous emboli capturing ability of the cardiogard cannula will be evaluated using a bubbles counter. .
|
36 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula
大体时间:36 months
|
Using the suction feature, External filters will be analyzed in order to recover particulate matter.
|
36 months
|
The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.
大体时间:36 months
|
The ability of the Cardiogard cannula will be evaluated using Neurological questionnaires.
|
36 months
|
合作者和调查者
调查人员
- 首席研究员:Gil - Bolotin, Prof.、Head of the Cardiac Surgery Department, Rambam Health Care Campus
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- CLNG100 Full Protocol
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
CardioGard Cannula的临床试验
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Icahn School of Medicine at Mount SinaiNational Heart, Lung, and Blood Institute (NHLBI)完全的
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Icahn School of Medicine at Mount SinaiNational Heart, Lung, and Blood Institute (NHLBI)招聘中