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
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
Treatments tested in this trial
- Interventional Left Ventricular Assist System
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov