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.
18≤Age≤80, any sex.
Failure to wean from CPB or refractory cardiogenic shock after cardiac surgery.
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).
Single group
SynFlow Duro
Devicea novel micro-axial flow pump for temporary left ventricular assistance
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)
Technical success rate
Technical success is defined as successful device placement, deployment, startup and explantation without any device malfunction
Cardiac index change versus baseline
Cardiac output change versus baseline
Pulmonary artery pressure change versus baseline
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