New heart pump could save lives after surgery shock
NCT ID NCT07560085
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study tests a new device called SynFlow Duro, a temporary heart pump for people who go into severe shock after heart surgery. About 60 adults in China will receive the pump to see if it helps their heart recover or keeps them stable until a transplant or permanent device. The goal is to improve survival and reduce the need for other emergency support.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Medical University Union Hospital
RECRUITINGFuzhou, Fujian, China
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Zhongnan Hospital of Wuhan University
RECRUITINGWuhan, Hubei, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stick-On patch aims to catch dangerous heart decline sooner
- Heart pump timing put to the test in deadly heart attack shock
- A second chance for the heart: can rehab rewrite the story after shock?
- Blood filter may calm the deadly inflammation of cardiogenic shock
- Microscopic blood vessel health may hold key to cardiogenic shock survival
- Can a machine support a failing heart without overworking it?