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An Interventional Left Ventricular Assist System for Cardiogenic Shock

ConditionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Medical University

About this trial

Imported Impella The price is relatively expensive and difficult for ordinary patients to afford. In order to better meet the growing clinical needs in China, Anhui Tongling Bionic Technology Co., Ltd. has developed an interventional left ventricular assist system. The test device was tested in preclinical animals It has shown good effectiveness and safety. Through the implementation of this clinical trial, the interventional left ventricular assist system The safety and effectiveness of the system for hemodynamic support in patients with cardiogenic shock have led to further development of this product in the country.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years old;

Refractory cardiogenic shock as determined by the cardiac MDT expert group; The criteria for refractory cardiogenic shock are: despite adequate doses of two vasoactive drugs and treatment of the underlying cause, there is still evidence of tissue hypoperfusion;

The subject can understand the purpose of the trial, voluntarily participate and sign the written informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.

Disqualifiers

Any peripheral vascular disease that prevents the placement of the trial device;

Left or right ventricular thrombus;

Aortic valve regurgitation, echocardiographic grade ≥2+;

Aortic valve stenosis, valve area ≤1.5cm2;

Trial design

Design model

Single group

Treatments tested in this trial

  • Interventional Left Ventricular Assist System

    Device

    Interventional left ventricular assist system for cardiogenic shock patients

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Interventional Left Ventricular Assist System Pre-trialExperimental treatment 1 intervention
Group B: Interventional Left Ventricular Assist System Formal ResearchExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Survival rate of subjects at discharge or 30 days after weaning from ventilator (whichever is longer)

Survival was defined as recovery of cardiac function or survival to bridging therapy; Recovery of cardiac function was defined as no need for any mechanical support or IABP assistance 30 days after removal of the invasive left ventricular assist system or at discharge (whichever was longer). Survival to bridging therapy was defined as survival to the induction of anesthesia for heart transplantation or placement of an implantable ventricular assist device.

Time frame
30days
2

The incidence of major adverse events at discharge or 30 days after weaning (whichever is longer)

Major adverse events included death and stroke.

Time frame
30days

Secondary outcomes

1

hemodynamic indicators

Immediately after surgery, before weaning, and 24 hours after weaning, researchers evaluated the improvement in the subjects' hemodynamics after implantation of the trial device. (cardiac index(L/min/m2), mean arterial pressure(mmHg), pulmonary diastolic pressure(mmHg))

Time frame
30days
2

Successful device placement and technical success

Successful device placement is defined as the successful placement of a disposable left ventricular catheter pump into the left ventricle via the artery, and the delivery system can be withdrawn smoothly. Technical success: After successful placement of the test device, blood can be pumped from the left ventricle into the ascending aorta, increasing the subject's cardiac output.

Time frame
30days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University

Lead sponsor

Source ClinicalTrials.gov
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