Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05291884
Status:
RECRUITING
Last Update Posted:
2023-06-08
First Post:
2022-02-11
Brief Title:
Use of the Impella BTR in Patients With Heart Failure An Early Feasibility Study
Sponsor:
Abiomed Inc
Organization:
Abiomed Inc
Study Overview
Official Title:
Use of the Impella BTR in Patients With Heart Failure An Early Feasibility Study
Status:
RECRUITING
Status Verified Date:
2023-06
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:
BTR EFS
Brief Summary:
This is a prospective multi-center single-arm early feasibility study that aims to evaluate the safety of the Impella BTR in adult patients requiring left-ventricular hemodynamic support and to evaluate the effectiveness of the Impella BTR in supporting patients to recovery or their next therapy
Detailed Description:
The objectives of this Early Feasibility Study are to evaluate the safety of the Impella BTR in adult patients requiring left-ventricular hemodynamic support Additionally to evaluate the feasibility of the Impella BTR in supporting patients to recovery or their next therapy The investigational device consists of the following primary device and accessories The Impella BTR Pump System an intravascular transvalvular micro-axial blood pump and the Modified Automated Impella Controller AIC to allow control of the Impella BTR
Following informed consent subjects that meet all of the inclusion and none of the exclusion criteria and in whom the Impella BTR is implanted or attempted to be implanted will be considered enrolled into the Study The device is inserted during a surgical procedure through a vascular graft that has been sutured onto the left or right axillary artery After proper placement and passage through the aortic valve with the help of a guidewire the device pumps blood from the left ventricle into the aorta Once hemodynamic support is no longer required the device is weaned and removed Subjects will be followed to 90 days post-implant
The primary and secondary endpoints will be summarized and presented without formal statistical testing All adverse events including all Protocol-defined events serious and non-serious will be documented and reported from the time of subject enrollment until Study completion Feasibility is defined as the ability of the pump to provide clinically adequate support for the duration of the implant up to 28 days Clinically adequate support is defined as operating without device malfunctions or failures that result in device removal replacement or use of an additional MCS device
Following informed consent subjects that meet all of the inclusion and none of the exclusion criteria and in whom the Impella BTR is implanted or attempted to be implanted will be considered enrolled into the Study The device is inserted during a surgical procedure through a vascular graft that has been sutured onto the left or right axillary artery After proper placement and passage through the aortic valve with the help of a guidewire the device pumps blood from the left ventricle into the aorta Once hemodynamic support is no longer required the device is weaned and removed Subjects will be followed to 90 days post-implant
The primary and secondary endpoints will be summarized and presented without formal statistical testing All adverse events including all Protocol-defined events serious and non-serious will be documented and reported from the time of subject enrollment until Study completion Feasibility is defined as the ability of the pump to provide clinically adequate support for the duration of the implant up to 28 days Clinically adequate support is defined as operating without device malfunctions or failures that result in device removal replacement or use of an additional MCS device
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