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.
Protocol Amendment History
12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2017-01-30; most recent amendment 2025-09-23.
Status change: Not Yet Recruiting → Active, Not Recruiting2017-03-10