Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock (COURAGE)
2026年8月31日 更新者：ForQaly Medical (Shanghai) Co., Ltd
Efficacy and Safety of SynFlow Duro System in the Treatment of Post Cardiotomy Cardiogenic Shock: a Prospective, Multicenter, Single-arm Clinical Trial
This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the treatment of post cardiotomy cardiogenic shock.
研究概览
详细说明
This study is a prospective, single-arm clinical trial to be conducted in at least 2 centers in China to evaluate the efficacy an safety of a novel micro-axial flow pump for left ventricular assistance in post cardiotomy cardiogenic shock.
The trial population includes those who fail to wean from cardiopulmonary bypass OR have refractory cardiogenic shock after cardiac surgery.
Patients with right heart failure will be excluded.
Eligible subjects will receive SynFlow system for bridging to cardiac recovery or durable cardiac therapy (cardiac transplantation or implantation of approved Ventricular Assist Device).
The primary endpoint is device support success, defined as survival to 30 days post-explant or hospital discharge (whichever is longer) OR to explantation in case of bridging to durable cardiac therapies.
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Chen Jiang
- 电话号码：+86 13918357410
- 邮箱：cjiang@forqaly.com
学习地点
-
-
Fujian
-
Fuzhou、Fujian、中国
- 招聘中
- Fujian Medical University Union Hospital
-
接触：
- Liangwan Chen
- 邮箱：chenliangwan@fjmu.edu.cn
-
-
Hubei
-
Wuhan、Hubei、中国
- 招聘中
- Zhongnan Hospital of Wuhan University
-
接触：
- Jinping Liu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 18≤Age≤80, any sex.
- Failure to wean from CPB or refractory cardiogenic shock after cardiac surgery.
Failure to wean from CPB is defined as failed to discontinue CPB or post-weaning CI <2.2L/min/m2 + PCWP >15mmHg, despite optimal pre-weaning management and receiving at least one high dose inotrope.
Refractory cardiogenic shock is defined as a condition that occurs despite adequate fluid status and meets all the following criteria:
① CI<2.2L/min/m2 + PCWP>15mmHg despite receiving at least one high dose inotrope or IABP; OR SBP <80mmHg or MAP<50mmHg despite receiving at least one high dose intrope + high dose norepinephrine or IABP.
② Presence of at least one signs indicating hypoperfusion: decreased mentation; cold, clammy, ashen or cyanotic extremities or skin or livedo reticularis; urine output<30ml/h or 0.5ml/kg/h; or lactate>2mmol/L or metabolic acidosis.
- Patient has signed the informed consent form.
Exclusion Criteria:
- Body surface area>2.5m2.
- Presence of any cardiac assist device (other than an IABP).
- Right ventricular failure.
- Evidence of any vascular disease or anatomy precluding placement or deployment of the device (e.g. severely calcified vessel).
- Evidence of ventricular thrombus.
- Moderate or severe aortic valve insufficiency/stenosis, or severe aortic valve calcification.
- Presence of mechanical aortic valve or cardiac contractile device.
- Obstructive, hypertrophic cardiomyopathy.
- Presence of uncorrected ventricular septal defect, atrial septal defect or patent foramen ovale.
- Mechanical manifestation of AMI (e.g. ventricular septal rupture, papillary muscle rupture, ventricular rupture).
- Any hematological disorder causing fragility of blood vessel or hemolysis.
- Known allergy or intolerant to heparin.
- Presence or suspicion of active systemic infection.
- Cardiopulmonary resuscitative maneuver lasting longer than 20 minutes before device placement.
- Sustained or non-sustained ventricular tachycardia or ventricular fibrillation unresponsive to medical therapy.
- Severe hepatic dysfunction, renal failure or severe respiratory failure
- Pregnant or lactating female.
- Concomitant enrollment in another investigational drug or device study where the primary endpoint has not yet been completed or that will clinically interfere with the endpoint of this investigation.
- Other conditions considered unsuitable for participating in this investigation by the investigators.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：SynFlow Duro
|
a novel micro-axial flow pump for temporary left ventricular assistance
|
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 |
|---|---|---|
|
Device support success
大体时间：Up to 30 days post-explant or hospital discharge (whichever is longer)
|
Cardiac recovery (survival to 30 days post-explant or hospital discharge [which is longer] without other mechanical support including IABP) or briging to other durable cardiac therapies (heart transplantation or implantation of approved durable ventricular assist device)
|
Up to 30 days post-explant or hospital discharge (whichever is longer)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Technical success rate
大体时间：Through device explantation, up to 14 days
|
Technical success is defined as successful device placement, deployment, startup and explantation without any device malfunction
|
Through device explantation, up to 14 days
|
|
Device support duration
大体时间：Through device explantation, up to 14 days
|
Time from device startup to device explanation
|
Through device explantation, up to 14 days
|
|
Time to recovery
大体时间：From device placement to 30 days post-explant or hospital discharge (whichever is longer)
|
Recovery is defined as survival to 30 days post-explant or hospital discharge (which is longer) without other mechanical support including IABP
|
From device placement to 30 days post-explant or hospital discharge (whichever is longer)
|
|
Major adverse event
大体时间：From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
Defined as stroke or death
|
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
|
Minor adverse event
大体时间：From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
Defined as minor or major bleeding, hemolysis, limb ischemia, requiring continuous renal placement therapy, ventricular tachycardia or fibrillation requiring cardioversion, sepsis, mechanical complications and major access vascular complications.
|
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
|
Adverse event
大体时间：From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
Defined as untoward medical event occurring during the course of clinical investigation, whether or not related to the medical device.
|
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
|
Serious adverse event
大体时间：From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
Defined as the event occurring during the course of clinical investigation, which leads to death or serious deterioration in the health, including a life-threatening illness or injury; a permanent impairment of a body structure or a body function; in-patient or prolonged hospitalization; medical or surgical intervention to prevent permanent impairment to a body structure or a body function; foetal distress, foetal death, congenital abnormality or birth defect, etc.
|
From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
|
|
Device deficiency
大体时间：Through device explantation, up to 14 days
|
Defined as the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical investigations, such as labeling errors, quality problems, malfunctions, etc.
|
Through device explantation, up to 14 days
|
|
Cardiac index change versus baseline
大体时间：Within 24 hours after device startup
|
Within 24 hours after device startup
|
|
|
Cardiac output change versus baseline
大体时间：Within 24 hours after device startup
|
Within 24 hours after device startup
|
|
|
Pulmonary artery pressure change versus baseline
大体时间：Within 24 hours after device startup
|
Within 24 hours after device startup
|
|
|
Mean arterial pressure change versus baseline
大体时间：Within 24 hours after device startup
|
Within 24 hours after device startup
|
|
|
Central venous pressure change versus baseline
大体时间：Within 24 hours after device startup
|
Within 24 hours after device startup
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Liangwan Chen、Fujian Medical University Union Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月14日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年4月19日
首先提交符合 QC 标准的
2026年4月23日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年9月2日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2026年8月1日
更多信息
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.