Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-27 @ 1:52 AM
Study NCT ID:
NCT02497950
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2015-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HeartMate 3 ELEVATE™ Registry
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Evaluating the HeartMate 3™ in a Post-Market Approval Setting: The HeartMate 3 Registry (ELEVATE™)
Status:
COMPLETED
Status Verified Date:
2024-04
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:
ELEVATE™
Brief Summary:
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
Detailed Description:
The purpose of this post-market registry is to collect data and evaluate the real-world experience of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) in a post-approval setting.
Study Oversight
Has Oversight DMC:
False
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?: