Efficacy and Safety of SynFlow Duro System in the Treatment of Post Cardiotomy Cardiogenic Shock: a Prospective, Multicenter, Single-arm Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- ForQaly Medical (Shanghai) Co., Ltd
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Device support success
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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\>2.5m
- •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).
Arms & Interventions
SynFlow Duro
Intervention: SynFlow Duro (Device)
Outcomes
Primary Outcomes
Device support success
Time Frame: 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 Outcomes
- Technical success rate(Through device explantation, up to 14 days)
- Cardiac index improvement versus baseline(Within 24 hours after device startup)
- Cardiac output improvement versus baseline(Within 24 hours after device startup)
- Pulmonary artery pressure improvement versus baseline(Within 24 hours after device startup)
- Mean arterial pressure improvement versus baseline(Within 24 hours after device startup)
- Central venous pressure improvement versus baseline(Within 24 hours after device startup)
- Device support duration(Through device explantation, up to 14 days)
- Time to recovery(From device placement to 30 days post-explant or hospital discharge (whichever is longer))
- Major adverse event(From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies)
- Minor adverse event(From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies)
- Adverse event(From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies)
- Serious adverse event(From device placement to 30 days post-explant or hospital discharge or bridging to other durable cardiac therapies)
- Device deficiency(Through device explantation, up to 14 days)