NCT06646224 Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock
| NCT ID | NCT06646224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shenzhen Core Medical Technology CO.,LTD. |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-12 |
| Primary Completion | 2025-05-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
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-mi