Actively Recruiting
Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock
Led by Shenzhen Core Medical Technology CO.,LTD. · Updated on 2024-10-17
50
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for providing circulatory support in patients with cardiogenic shock caused by cardiomyopathy. This will be assessed through a prospective, multicenter, single-arm clinical trial involving patients with cardiogenic shock. The focus will be on determining the device's ability to improve survival outcomes and reduce the risk of related adverse events in these patients.
CONDITIONS
Official Title
Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old (inclusive)
- Heart failure or cardiac dysfunction caused by cardiomyopathy
- Cardiogenic shock with either rapidly worsening hemodynamic instability requiring repeated vasopressors and impaired left ventricular function, or severe cardiogenic shock with low cardiac index, specific vasoactive medication doses, low blood pressure, and impaired left ventricular function
- Two consecutive blood lactate measurements equal to or above 3.0 mmol/L at least 30 minutes apart
- Ability to understand the study purpose, sign informed consent, comply after discharge, and complete clinical follow-up
You will not qualify if you...
- Continuous cardiopulmonary resuscitation that cannot restore circulation
- Inability to implant or use CorVad due to conditions like left ventricular thrombus, artificial aortic valve, severe aortic valve disease, aortic abnormalities, blood cell fragility, or hemolytic disorders
- Inability to use heparin for anticoagulation
- Shock caused by reasons other than cardiomyopathy, such as myocardial infarction, arrhythmia, hypovolemia, or septic shock
- Unrepaired cardiac structural damage like chordal rupture, ventricular septal perforation, or free wall rupture
- Severe right heart failure
- Pregnant or breastfeeding women
- Participation in another ongoing drug or device clinical trial without primary endpoint reached
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
X
Xiaoli Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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