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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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:
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 ve…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it even be a realistic option for me given how quickly cardiogenic shock after heart surgery needs to be treated?
2The trial is studying a catheter-based device to unload and support the left ventricle after heart surgery — how does this approach compare to the mechanical support options that are already available to me right now if I develop cardiogenic shock?
3Since this trial is Phase NA, meaning it doesn't fit the usual Phase 1-3 structure, can you help me understand what that means for how much safety and effectiveness data already exists for this specific device in post-surgery cardiogenic shock?
4The main thing being measured is 'device support success' — can you explain what that means in practice, and what happens to my care if the device doesn't meet that goal during the trial?
5Because cardiogenic shock after cardiac surgery is a life-threatening emergency, how would enrollment in this trial actually work — would I or my family have any real time to review and consent, or would decisions need to happen extremely fast?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Device support success
Timeframe: Up to 30 days post-explant or hospital discharge (whichever is longer)