Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock (COURAGE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Device: SynFlow Duro

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen Jiang; Phone Number: +86 13918357410; Email: cjiang@forqaly.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Fujian Medical University Union Hospital
      • Contact: Liangwan Chen; Email: chenliangwan@fjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SynFlow Duro	Device: SynFlow Duro; a novel micro-axial flow pump for temporary left ventricular assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device support success	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	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	Time from device startup to device explanation	Through device explantation, up to 14 days
Time to recovery	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	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	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	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	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	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		Within 24 hours after device startup
Cardiac output change versus baseline		Within 24 hours after device startup
Pulmonary artery pressure change versus baseline		Within 24 hours after device startup
Mean arterial pressure change versus baseline		Within 24 hours after device startup
Central venous pressure change versus baseline		Within 24 hours after device startup

Collaborators and Investigators

• Sponsor: ForQaly Medical (Shanghai) Co., Ltd
• Investigators: Study Chair: Liangwan Chen, Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Shock, Cardiogenic
• Other Study ID Numbers: CSPR001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No