NCT04235491

Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)

Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 37,000 (estimated)
• Sponsor: Medtronic · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Detailed description

The Micra AV CED study is a study of the Medicare beneficiary population implanted with Micra AV leadless pacemakers or dual-chamber transvenous 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 AV leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra AV leadless pacemakers to dual-chamber 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.

Conditions

• Bradycardia

Timeline

• Start date: 2020-02-06
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2020-01-22
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States