Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock

NCT07560085 | Not Yet Recruiting

• 1 other identifier: CSPR001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock

Outcome Measures

Primary Outcomes (1)

• Device support success

  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)

  Up to 30 days post-explant or hospital discharge (whichever is longer)

Secondary Outcomes (13)

• Technical success rate

  Through device explantation, up to 14 days

• Cardiac index change versus baseline

  Within 24 hours after device startup

• Cardiac output change versus baseline

  Within 24 hours after device startup

• Pulmonary artery pressure change versus baseline

  Within 24 hours after device startup

• Mean arterial pressure change versus baseline

  Within 24 hours after device startup

Study Arms (1)

SynFlow Duro

EXPERIMENTAL

Device: SynFlow Duro

Interventions

SynFlow Duro DEVICE

a novel micro-axial flow pump for temporary left ventricular assistance

SynFlow Duro

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ForQaly Medical (Shanghai) Co., Ltd: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Liangwan Chen

  Fujian Medical University Union Hospital

  STUDY CHAIR

Central Study Contacts

Chen Jiang

CONTACT

+86 13918357410; cjiang@forqaly.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)