Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Ca… (NCT07560085) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
China60 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
â‘ 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\>2.5m2.
* 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 v…
What they're measuring
1
Device support success
Timeframe: Up to 30 days post-explant or hospital discharge (whichever is longer)