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.
This prospective, multicenter, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the survival rate of subjects. The survival rate is defined as follows: * 1\. Recovery: Survival at 30 days post-device removal or at discharge (whichever is longer); * 2\. Bridge to Other Therapy: Survival at 30 days post-heart transplantation or left ventricular assist device (LVAD) implantation. The study plans to enroll 50 subjects. The target population consists of patients with cardiogenic shock caused by cardiomyopathy who provide informed consent through a form approved by the Ethics Committee (EC). Subjects who meet the enrollment criteria, as determined by the investigator, will receive the trial device in accordance with study requirements and will be followed up to assess the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The CorVad Percutaneous Ventricular Assist System provides circulatory support for patients with cardiogenic shock.
Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen
Shenzhen, Guangdong, China
RECRUITINGSurvival Rate of Subjects
Survival is defined as: 1. Recovery: Survival at 30 days post device removal or at discharge (whichever is longer); 2. Bridge to Other Therapy: Survival at 30 days post heart transplantation or left ventricular assist device (LVAD) implantation.
Time frame: Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation
In-Hospital Mortality Rate
Time frame: 30 days post-CorVad removal or discharge (which is longer)
14-Day Mortality Rate After CorVad Removal
Time frame: 14 days post-CorVad removal
Stroke
Time frame: Within 30 days post-CorVad removal
Cardiovascular-Cause Mortality
Time frame: Within 30 days post-CorVad removal
Re-Hospitalization Due to Cardiovascular Reasons
Re-hospitalization for cardiovascular disease
Time frame: Within 30 days post-CorVad removal
MCS-ARC Type 3, 4, 5 Bleeding
Time frame: Within 30 days post-CorVad removal
Serious Device-Related Adverse Events
Serious device-related adverse events include but are not limited to cardiac structural damage, severe limb ischemia (pallor, pulselessness, and necrosis), puncture site infection, acute kidney injury, arrhythmias requiring cardiopulmonary resuscitation, damage to the aorta and aortic valve, hemolysis resulting in subject death, permanent or serious disability, significantly prolonged hospital stay, or surgical intervention required.
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Time frame: Within 30 days post-CorVad removal
Duration of Device Use
Time frame: Recovery: 30 days post-CorVad removal or discharge (which is longer); Bridge to Other Therapy: 30 days post-heart transplantation or LVAD implantation
Device Malfunction
Device malfunction is defined as a flow rate of less than 1L/min at S5 or higher speed level lasting more than 5 minutes
Time frame: During CorVad operation