Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-01-16 @ 3:29 PM
Study NCT ID:
NCT03039712
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2017-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Sponsor:
Medtronic
Organization:
Study Overview
Official Title:
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
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:
Micra CED
Brief Summary:
The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with single-chamber ventricular pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.
Detailed Description:
Micra CED study is a study of the Medicare beneficiary population implanted with single-chamber ventricular pacemakers, and will be executed by analyzing administrative claims data. The study consists of two primary objectives: estimate the: (1) acute overall complication rate and (2) the 2-year survival rate of patients implanted with a Micra leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra leadless pacemakers to single-chamber ventricular transvenous pacemakers will be conducted.
The analysis will be in CMS claims data and is subject to a central IRB. However, individual hospitals are not engaged in research and local IRB oversight is not necessary.
The analysis will be in CMS claims data and is subject to a central IRB. However, individual hospitals are not engaged in research and local IRB oversight is not necessary.
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?:
False
Is an FDA AA801 Violation?: