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.
Protocol Amendment History
8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2020-01-16; most recent amendment 2025-09-23.
Status change: Not Yet Recruiting → Active, Not Recruiting2020-02-21