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

StatusActive, Not Recruiting
PhaseNot specified
SponsorMedtronic
Started
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Record History

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  1. Secondary endpoints: details revised at 2 of 2 entries
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 2 words
  2. Primary and study completion dates: Jun 2027 to Jun 2029v9
  3. 2 versions Re-verified since Jun 21, 2023, no change to tracked fieldsv7-v8
  4. Primary and study completion dates: Jun 2024 to Jun 2027v6
  5. 2 versions Re-verified since Feb 11, 2021, no change to tracked fieldsv4-v5
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  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Feb 2020 to Feb 6, 2020
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Medtronic
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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.
Trial Details
NCT Number NCT04235491
Lead Sponsor Medtronic
Conditions
(from sponsor)		 Bradycardia
Related terms Bradycardia
Enrollment 37,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov