Left ventricular unloading with a micro-axial pump after heart surgery for post-cardiotomy cardiogenic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, single-arm study conducted in China to assess the safety and effectiveness of the SynFlow Duro micro-axial left ventricular assist device in patients with post-cardiotomy cardiogenic shock. Eligible participants are adults up to 80 years old who fail to wean from cardiopulmonary bypass or have refractory shock after surgery, excluding those with right heart failure. The device is used to bridge patients to recovery or to durable cardiac therapies such as transplantation or a ventricular assist device. The primary endpoint is device support success, defined as survival to 30 days after explant or hospital discharge, or after explantation when bridging to durable therapy occurs.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Chen Jiang
• Email: cjiang@forqaly.com
• Phone: +86 13918357410

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.