Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646224
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Efficacy and Safety of the CorVad Percutaneous Ventricular Assist System in Cardiogenic Shock
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 devices 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None