Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306573
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-12
First Post:
2023-11-14
Brief Title:
CardioMEMS HF System Real-World Evidence Post-Approval Study
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
CardioMEMS HF System Real-World Evidence Post-Approval Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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 purpose of this post-approval study PAS is to evaluate the long-term safety and effectiveness of the CardioMEMS HF System using real-world evidence RWE methods
Detailed Description:
Subjects will be identified in Abbotts Merlinnet remote monitoring database Merlinnet data will be linked to Medicare fee-for-service FFS claims data to longitudinally track outcomes Each subject will be followed for a minimum of 36 months
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?:
True
Is an FDA AA801 Violation?:
None