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RECRUITINGINTERVENTIONAL

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

A Clinical Trial to Evaluate the Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in the Treatment of Cardiogenic Shock Caused by Cardiomyopathy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form, demonstrate good compliance after discharge, and be willing to complete clinical follow-up. Who Should NOT Join This Trial: - 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.). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

CorVad Percutaneous Ventricular Assist System

The CorVad Percutaneous Ventricular Assist System provides circulatory support for patients with cardiogenic shock.

Locations (1)

Fuwai Hospital Chinese Academy of Medical Sciences.Shenzhen
Shenzhen, Guangdong, China