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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
a novel micro-axial flow pump for temporary left ventricular assistance
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
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)
Time frame: Up to 30 days post-explant or hospital discharge (whichever is longer)
Technical success rate
Technical success is defined as successful device placement, deployment, startup and explantation without any device malfunction
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 from device startup to device explanation
Time frame: Through device explantation, up to 14 days
Time to recovery
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Recovery is defined as survival to 30 days post-explant or hospital discharge (which is longer) without other mechanical support including IABP
Time frame: From device placement to 30 days post-explant or hospital discharge (whichever is longer)
Major adverse event
Defined as stroke or death
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through device explantation, up to 14 days