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Active Not Recruiting
NCT03039712
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Conditions: Bradycardia
Sex: All
Healthy volunteers: No
Enrollment: 37000
Sponsor: Medtronic
Location: Emory University Atlanta Georgia
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT03039712). StuddyBuddy aggregates publicly available trial information.
