Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Sponsored by Medtronic
About this trial
Last updated a year ago
Study ID
Micra CED Study
Status
Active, not recruiting
Type
Observational
Placebo
No
Accepting
All
All
Not accepting
Healthy Volunteers
Trial Timing
Started 8 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
• Medicare beneficiaries implanted with a 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 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
For more information, view the full study details:
NCT03039712