Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04477603
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2020-07-13
Brief Title:
Impella ECP Early Feasibility Study
Sponsor:
Abiomed Inc
Organization:
Abiomed Inc
Study Overview
Official Title:
Use of the Impella ECP in Patients Undergoing an Elective or Urgent High-Risk Percutaneous Coronary Intervention an Early Feasibility Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
ECP EFS
Brief Summary:
The Impella ECP EFS is a prospective multicenter single-arm feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention
Detailed Description:
This is a prospective multicenter single-arm feasibility study evaluating the safety of the Impella ECP device in adult patients undergoing an elective or urgent high-risk percutaneous coronary intervention HRPCI Additionally this study will evaluate the feasibility of placing the ECP pump across the aortic valve without the use of a guidewire and assess the ability of the pump to provide sufficient hemodynamic support during a HRPCI Investigational device products include Impella ECP pump system a percutaneous transvalvular micro-axial blood pump 9Fr introducer sheath and the automated Impella controller with revised console software to allow control of the Impella ECP
Following informed consent subjects eligible for a HRPCI that meet all of the inclusion and none of the exclusion criteria will be enrolled into the study The intended coronary intervention is then carried out under mechanical circulatory support by the Investigational Device This device is inserted through a sheath that has been deployed through a femoral puncture following crimping of the Impella ECP After proper placement and wireless passage of the aortic valve the device pumps blood from the left ventricle into the aorta Once the interventional procedure is completed the device is weaned and removed Subjects will be followed up until 30 days post intervention
The primary and secondary end points will be summarized and presented without formal statistical testing Safety will be assessed by the rate of composite Major Device-Related Adverse Events evaluated at the end of the HRPCI procedure Feasibility is defined as the successful delivery initiation and maintenance of sufficient hemodynamic support to increase in or maintenance the MAP at physiologic levels 60 mmHg evaluated up to the end of procedure
Following informed consent subjects eligible for a HRPCI that meet all of the inclusion and none of the exclusion criteria will be enrolled into the study The intended coronary intervention is then carried out under mechanical circulatory support by the Investigational Device This device is inserted through a sheath that has been deployed through a femoral puncture following crimping of the Impella ECP After proper placement and wireless passage of the aortic valve the device pumps blood from the left ventricle into the aorta Once the interventional procedure is completed the device is weaned and removed Subjects will be followed up until 30 days post intervention
The primary and secondary end points will be summarized and presented without formal statistical testing Safety will be assessed by the rate of composite Major Device-Related Adverse Events evaluated at the end of the HRPCI procedure Feasibility is defined as the successful delivery initiation and maintenance of sufficient hemodynamic support to increase in or maintenance the MAP at physiologic levels 60 mmHg evaluated up to the end of procedure
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