Cardiogenic ShockCOURAGENCT07560085
Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
A study testing SynFlow Duro in people with Cardiogenic Shock, run by ForQaly Medical (Shanghai) Co., Ltd at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- SynFlow Duro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 14 Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Liangwan Chen, chenliangwan@fjmu.edu.cn
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Jinping Liu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiogenic Shock
- Being tested
- SynFlow Duro
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynFlow DuroDevice
a novel micro-axial flow pump for temporary left ventricular assistance
| Study group | Role | What they receive |
|---|---|---|
| SynFlow Duro | Experimental | Not described Receives: Device: SynFlow Duro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 30 days post-explant or hospital discharge (whichever is longer)
Secondary outcomes (13)
Technical success rate
Technical success is defined as successful device placement, deployment, startup and explantation without any device malfunction
Measured: Through device explantation, up to 14 days
Cardiac index change versus baseline
Measured: Within 24 hours after device startup
Cardiac output change versus baseline
Measured: Within 24 hours after device startup
Pulmonary artery pressure change versus baseline
Measured: Within 24 hours after device startup
Mean arterial pressure change versus baseline
Measured: Within 24 hours after device startup
Central venous pressure change versus baseline
Measured: Within 24 hours after device startup
Device support duration
Time from device startup to device explanation
Measured: 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
Measured: From device placement to 30 days post-explant or hospital discharge (whichever is longer)
Major adverse event
Defined as stroke or death
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through device explantation, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start14 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ForQaly Medical (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liangwan Chen, Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560085
- Sponsor's protocol ID
- CSPR001
- Acronym
- COURAGE
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of SynFlow Duro System in the Treatment of Post Cardiotomy Cardiogenic Shock: a Prospective, Multicenter, Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07560085
- Acronym / sponsor ID
- COURAGE / CSPR001
- Conditions
- Cardiogenic Shock
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ForQaly Medical (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SynFlow Duro | Experimental | Device: SynFlow Duro |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SynFlow Duroa novel micro-axial flow pump for temporary left ventricular assistance | Device | SynFlow Duro |
Primary outcome
Device support success
Time frame: 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)
13 secondary outcomes
Technical success rate
Time frame: Through device explantation, up to 14 days
Cardiac index change versus baseline
Time frame: Within 24 hours after device startup
Cardiac output change versus baseline
Time frame: Within 24 hours after device startup
Pulmonary artery pressure change versus baseline
Time frame: Within 24 hours after device startup
Mean arterial pressure change versus baseline
Time frame: Within 24 hours after device startup
Central venous pressure change versus baseline
Time frame: Within 24 hours after device startup
Device support duration
Time frame: Through device explantation, up to 14 days
Time to recovery
Time frame: From device placement to 30 days post-explant or hospital discharge (whichever is longer)
Major adverse event
Time frame: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Minor adverse event
Time frame: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Adverse event
Time frame: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Serious adverse event
Time frame: From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies
Device deficiency
Time frame: Through device explantation, up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liangwan Chen study chair
Fujian Medical University Union Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SynFlow Duro in people with Cardiogenic Shock, run by ForQaly Medical (Shanghai) Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chen Jiang (+86 13918357410, cjiang@forqaly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device support success (time frame: Up to 30 days post-explant or hospital discharge (whichever is longer)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.