Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05727059
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2023-01-25
Brief Title:
Magenta Elevate EFS in High-Risk PCI Patients
Sponsor:
Magenta Medical Ltd
Organization:
Magenta Medical Ltd
Study Overview
Official Title:
Early Feasibility Study EFS of the Magenta Elevate Percutaneous Left Ventricular Assist Device pLVAD System in Patients Undergoing Non-emergent High-risk Percutaneous Coronary Interventions
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Elevate EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate percutaneous Left Ventricular Assist Device pLVAD System in patients undergoing non-emergent high-risk percutaneous coronary interventions
Detailed Description:
The Elevate EFS is planned as a prospective single-arm interventional multi-center study enrolling up to 20 subjects
The Magenta Elevate Pump is a catheter-mounted self-expanding and retrievable pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta
The Magenta Elevate is a temporary 6 hours ventricular support device indicated for use during high-risk percutaneous coronary interventions PCI performed electively or urgently in hemodynamically stable patients with severe coronary artery disease
The Magenta Elevate Pump is a catheter-mounted self-expanding and retrievable pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta
The Magenta Elevate is a temporary 6 hours ventricular support device indicated for use during high-risk percutaneous coronary interventions PCI performed electively or urgently in hemodynamically stable patients with severe coronary artery disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None