Cardiogenic Shock
Conditions
Brief 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.
Detailed description
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.
Interventions
DEVICESynFlow Duro
a novel micro-axial flow pump for temporary left ventricular assistance
Sponsors
ForQaly Medical (Shanghai) Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse event | From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies | Defined as stroke or death |
| Minor adverse event | From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies | 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. |
| Adverse event | From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies | Defined as untoward medical event occurring during the course of clinical investigation, whether or not related to the medical device. |
| Device support duration | Through device explantation, up to 14 days | Time from device startup to device explanation |
| Technical success rate | Through device explantation, up to 14 days | Technical success is defined as successful device placement, deployment, startup and explantation without any device malfunction |
| Cardiac index change versus baseline | Within 24 hours after device startup | — |
| Cardiac output change versus baseline | Within 24 hours after device startup | — |
| Pulmonary artery pressure change versus baseline | Within 24 hours after device startup | — |
| Mean arterial pressure change versus baseline | Within 24 hours after device startup | — |
| Central venous pressure change versus baseline | Within 24 hours after device startup | — |
| Serious adverse event | From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies | 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 to recovery | From device placement to 30 days post-explant or hospital discharge (whichever is longer) | Recovery is defined as survival to 30 days post-explant or hospital discharge (which is longer) without other mechanical support including IABP |
| Device deficiency | Through device explantation, up to 14 days | 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. |
Countries
China
Contacts
CONTACTChen Jiang
STUDY_CHAIRLiangwan Chen
Fujian Medical University Union Hospital
Outcome results
None listed