Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/20/2019 |
| Start Date: | March 10, 2017 |
| End Date: | June 2021 |
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
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
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.
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.
Inclusion Criteria:
• Medicare beneficiaries implanted with a leadless pacemaker (CPT 0387T or ICD-10 PCS
02HK3NZ) on or after the study start date will be included in the study.
or
• Medicare beneficiaries with implanted with a full system single-chamber ventricular
transvenous pacemaker (CPT 33207 or ICD-10 PCS 0JH605Z or 0JH604Z and 02HK3JZ) on or after
the study start date.
Exclusion Criteria:
• None
We found this trial at
1
site
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
Click here to add this to my saved trials
