SynFlow Duro: a novel micro-axial flow pump for temporary left ventricular assistance
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Device support success — 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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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