Actively Recruiting
Evaluation of an Interventional Left Ventricular Assist System for Hemodynamic Support in Cardiogenic Shock: A Prospective, Multicenter, Single-group Study
Led by Fujian Medical University · Updated on 2024-07-08
60
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an interventional left ventricular assist system designed to provide hemodynamic support for patients experiencing cardiogenic shock, a severe condition related to heart disease with high mortality rates. The study aims to assess the safety and effectiveness of this new device, which was developed in China to offer a more affordable alternative to imported devices like the Impella system. The device has shown promising results in preclinical animal testing, and this trial seeks to further develop and validate its clinical use. The study includes two phases: an initial pre-trial with 6 subjects to preliminarily evaluate safety and effectiveness, followed by a formal research phase involving about 54 patients. The interventional device works by assisting the left ventricle through a catheter-based axial flow pump, aiming to improve cardiac output and reduce heart stress. Participants receive this device support to help manage cardiogenic shock, with the study monitoring device placement success and hemodynamic changes. Participants will be closely monitored throughout the study, with primary outcomes focusing on survival rates at discharge or 30 days after device removal and the incidence of major adverse events in the same period. Secondary outcomes include hemodynamic indicators and technical success of device placement. The study involves follow-up visits and assessments to track patient progress and safety, with a total participation period covering the initial treatment and 30 days afterward for outcome evaluation.
CONDITIONS
Brief 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
- Diagnosis of refractory cardiogenic shock as determined by cardiac expert group
- Ability to understand the trial purpose and voluntarily sign informed consent
- Agreement to complete follow-up as required by the protocol
- For formal research phase: low cardiac output syndrome or increased filling pressure after cardiac surgery with specific inotropic drug use
- Ability to understand the trial purpose and voluntarily sign informed consent in formal phase
- Agreement to complete follow-up as required by the protocol in formal phase
You will not qualify if you...
- Right heart failure with central venous pressure-capillary wedge pressure ≥10mmHg or cardiac tamponade
- Peripheral vascular disease preventing device placement
- Presence of 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 defects
- Patent foramen ovale
- Mechanical complications of acute myocardial infarction
- Diseases causing hemolysis or increased blood cell fragility
- Cardiopulmonary resuscitation lasting over 15 minutes within 24 hours before device implantation
- Ventricular tachycardia or fibrillation unresponsive to drugs
- Renal failure with elevated serum creatinine or blood urea nitrogen
- Liver failure with elevated bilirubin
- Allergy or intolerance to heparin
- Presence of other cardiac assist devices
- Active systemic infection
- Refusal to sign consent or failure to complete follow-up
- Pregnancy, lactation, or inability/unwillingness to use effective contraception
- Participation in other clinical trials within 3 months or ongoing trials
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive the interventional left ventricular assist system to support heart function during cardiogenic shock.
1 implantation visit and follow-up visits until device weaning or discharge
Duration - Up to 30 days after device weaning or discharge
Participants are monitored for survival, safety, and effectiveness outcomes after device weaning or discharge.
Follow-up visits as required up to 30 days
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here