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

NCT04235491 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 37000

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Bradycardia

Sponsors & Collaborators

Principal Investigators

  • Mikhael El Chami, MD · Emory University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-06
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04235491 on ClinicalTrials.gov