NCT06646224

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shenzhen Core Medical Technology CO.,LTD. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	CorVad Percutaneous Ventricular Assist System	The CorVad Percutaneous Ventricular Assist System provides circulatory support for patients with cardiogenic shock.

Timeline

• Start date: 2024-10-12
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2024-10-17
• Last updated: 2024-10-17

Locations

1 site across 1 country: China