NCT07560085 Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
| NCT ID | NCT07560085 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ForQaly Medical (Shanghai) Co., Ltd |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-14 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-07-14 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Liangwan Chen
STUDY CHAIR
Fujian Medical University Union Hospital
Frequently Asked Questions
Who can join the NCT07560085 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07560085 currently recruiting?
Yes, NCT07560085 is actively recruiting participants. Contact the research team at cjiang@forqaly.com for enrollment information.
Where is the NCT07560085 trial being conducted?
This trial is being conducted at Fuzhou, China, Wuhan, China.
Who is sponsoring the NCT07560085 clinical trial?
NCT07560085 is sponsored by ForQaly Medical (Shanghai) Co., Ltd. The principal investigator is Liangwan Chen at Fujian Medical University Union Hospital. The trial plans to enroll 60 participants.