Ignite Creation Date:
2024-05-06 @ 9:04 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02892955
Status:
COMPLETED
Last Update Posted:
2022-06-27
First Post:
2016-08-24
Brief Title:
MOMENTUM 3 Continued Access Protocol
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3 Continued Access Protocol Post-Approval Continued Follow-up
Status:
COMPLETED
Status Verified Date:
2022-06
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:
MOMENTUM 3 CAP
Brief Summary:
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced refractory left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study
Detailed Description:
Enrollment in the CAP cohort ended shortly after approval for the long-term indication was received from the FDA in October 2018 As a condition of approval all patients enrolled in the CAP cohort were to complete the 2-year follow-up to fulfil a post-approval study requirement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None