Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock

Launched by SHENZHEN CORE MEDICAL TECHNOLOGY CO.,LTD. · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the CorVad Percutaneous Ventricular Assist System, a device designed to help patients with a serious condition called cardiogenic shock, which happens when the heart can't pump enough blood to meet the body's needs. The trial aims to find out how safe and effective this device is in improving survival rates and reducing complications for people suffering from this condition due to heart muscle problems known as cardiomyopathy.

To participate in the trial, individuals must be between 18 and 80 years old and experiencing cardiogenic shock, which can be identified through specific heart function tests and symptoms. Participants can expect to receive close medical monitoring and support throughout the trial. It’s important to note that some patients may not be eligible due to certain heart conditions or other health issues. If you or a loved one is dealing with this severe health challenge, this trial could offer an opportunity to access new treatment options while helping advance medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age of subjects must be between 18 and 80 years old (inclusive).
• • 2. Presence of heart failure or cardiac dysfunction caused by cardiomyopathy.
• * 3. Occurrence of cardiogenic shock under adequate blood volume, which must meet one of the following conditions:
• • 1. Rapidly Worsening Cardiogenic Shock: Progressive hemodynamic instability requiring repeated administration of vasopressors to maintain mean arterial pressure \>50 mmHg, and left ventricular systolic function is impaired (LVEF \<35% or LVEF 35-55% with significant mitral regurgitation).
• • 2. Severe Cardiogenic Shock: Cardiac index (CI) \< 2.2 L/min/m² + norepinephrine dose \> 0.1 µg/kg/min + dopamine or dobutamine dose \> 10 µg/kg/min; systolic blood pressure \< 90 mmHg + norepinephrine dose \> 0.2 µg/kg/min + dopamine or dobutamine dose \> 10 µg/kg/min + LVEF \< 35% or LVEF 35-55% with significant mitral regurgitation.
• • 4. Two consecutive blood lactate measurements ≥ 3.0 mmol/L (with at least a 30-minute interval).
• • 5. The subject or their guardian must be able to understand the purpose of the trial, sign the informed consent form, demonstrate good compliance after discharge, and be willing to complete clinical follow-up.
• Exclusion Criteria:
• • 1. Continuous cardiopulmonary resuscitation (CPR) cannot restore circulation.
• • 2. CorVad cannot be implanted or applied (including but not limited to left ventricular mural thrombus, presence of artificial aortic valve or cardiac contraction devices, moderate to severe aortic stenosis, moderate to severe aortic regurgitation, aortic dissection, aneurysm, or severe abnormalities of the ascending aorta and/or aortic arch, blood cell fragility, or hemolytic blood disorders).
• • 3. Inability to use heparin for anticoagulation therapy.
• • 4. Shock caused by other reasons (e.g., myocardial infarction, arrhythmia, hypovolemia, septic shock, etc.).
• • 5. Presence of unrepaired cardiac structural damage (e.g., chordal rupture, ventricular septal perforation, free wall rupture, etc.).
• • 6. Severe right heart failure.
• • 7. Pregnant or breastfeeding women.
• • 8. Currently participating in another clinical trial of a drug or device that has not yet reached its primary endpoint.
• • 9. Any other circumstances deemed inappropriate for inclusion in this study by the investigator.