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

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

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.

Conditions2

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