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.
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.
Study Type
OBSERVATIONAL
Enrollment
37,000
Emory University
Atlanta, Georgia, United States
Acute complication rate
Micra AV leadless pacemaker system and/or procedure related complications at 30 days. Acute complications include embolism/thrombosis, event at the puncture site, cardiac effusion/perforation, device-related complication, or other complications following the implantation of a Micra AV leadless pacemaker system. Subjects' administrative claims data will be reviewed to determine the occurrence of an acute complication.
Time frame: 30 days
The 2-year survival of patients implanted with a Micra AV leadless pacemaker
Estimate the 2-year survival rate of patients implanted with a Micra AV leadless pacemaker
Time frame: 2 years
Chronic complication rate
Chronic complications are a subset of acute complications that may also occur within six months following the implantation of a Micra AV leadless pacemaker. Micra AV leadless pacemaker system and/or procedure related complications at six months. Subjects' administrative claims data will be reviewed to determine the occurrence of a chronic complication.
Time frame: 6 months
Device-related re-intervention rates
Device-related re-interventions are procedures associated with the insertion/replacement, revision, or removal or either a leadless or transvenous pacemaker system or components following the index implantation of a Micra AV leadless pacemaker. Device-related re-intervention rates will be reported at six month intervals for two years following the index implantation of a single-chamber ventricular pacemaker. Subjects' administrative claims data will be reviewed to determine the occurrence of a device-related re-intervention.
Time frame: 2 years
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