Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

37000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-06

Study Completion Date

2029-06-30

Brief Summary

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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 Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

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Detailed Description

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The Micra AV CED study is a study of the Medicare beneficiary population implanted with Micra AV leadless pacemakers or dual-chamber transvenous 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 AV leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra AV leadless pacemakers to dual-chamber 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.

Conditions

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Bradycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Micra AV leadless pacemaker therapy

All Medicare patients implanted with a Micra AV leadless pacemaker system

No interventions assigned to this group

Dual Chamber Transvenous pacemaker

All Medicare patients implanted with full system (e.g. lead and generator) dual-chamber transvenous pacemakers

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Medicare beneficiaries implanted with a Micra AV leadless pacemaker (CPT 0387T or 33274 or ICD-10 PCS 02HK3NZ) on or after the study start date will be included in the study.

or

\- Medicare beneficiaries implanted with a dual-chamber ventricular transvenous pacemaker \[CPT 33208 or 33213 or 33214 or ICD-10 PCS ((0JH606Z or 0JH636Z) + (02H60JZ or 02H63JZ or 02H70JZ or 02H73JZ) + (02HK0JZ or 02HK3JZ))\] on or after the study start date.