Actively Recruiting
An Interventional Left Ventricular Assist System for Cardiogenic Shock
Led by Fujian Medical University · Updated on 2024-07-08
60
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Interventional Left Ventricular Assist System for Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Having refractory cardiogenic shock despite adequate doses of two vasoactive drugs and treatment of the underlying cause
- Ability to understand the trial and voluntarily sign informed consent
- Agreeing to complete follow-up as required by the study protocol
- For formal research phase: Low cardiac output syndrome or increased filling pressure after cardiac surgery with specific inotropic drug use within 48 hours
- Ability to understand the trial and voluntarily sign informed consent for the formal phase
- Agreeing to complete follow-up as required by the study protocol
You will not qualify if you...
- Right heart failure with central venous pressure-capillary wedge pressure 10mmHg, or central venous pressure-pulmonary artery diastolic pressure 10mmHg, or cardiac tamponade
- Peripheral vascular disease preventing device placement
- Left or right ventricular thrombus
- Aortic valve regurgitation grade 2 or higher
- Aortic valve stenosis with valve area 1.5cm2
- Aortic valve calcification
- Presence of mechanical aortic valve
- Hypertrophic or obstructive cardiomyopathy
- Untreated ventricular or atrial septal defect
- Patent foramen ovale
- Mechanical complications after acute myocardial infarction
- Diseases causing hemolysis such as hereditary spherocytosis or autoimmune hemolytic anemia
- Cardiopulmonary resuscitation over 15 minutes within 24 hours before device implantation
- Ventricular tachycardia or fibrillation unresponsive to drugs
- Renal failure with serum creatinine 309.4umol/l or blood urea nitrogen 35.7mmol/l
- Liver failure with total bilirubin 85.5umol/l
- Allergy or intolerance to heparin
- Presence of any other cardiac assist device
- Active systemic infection
- Refusal to sign informed consent or failure to complete follow-up
- Pregnant or lactating women or women unwilling or unable to use contraception
- Participation in other clinical trials within last 3 months or ongoing trials
- Other conditions judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Cardiovascular Surgery
Fuzhou, Fujian, China, 350001
Actively Recruiting
2
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
Research Team
L
Liang-wan Chen, M.D Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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