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Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers

Study acronym: Micra 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 3 of 3 entries
  2. Primary and study completion dates: Jun 2027 to Jun 2029v13
  3. 2 versions Re-verified since Jun 21, 2023, no change to tracked fieldsv11-v12
  4. Primary completion date: Jun 2024 to Jun 2027
    • Study completion date: Jun 2025 to Jun 2027
    v10
  5. Primary completion date: Jun 2021 to Jun 2024v9
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  1. Eligibility criteria revisedv8
  2. Eligibility criteria expanded, about 2 wordsv7
  3. Study completion date: Jun 2021 to Jun 2025v6
  4. 2 versions Re-verified since Jan 17, 2019, no change to tracked fieldsv4-v5
  5. Enrollment target: 7000 to 37000
    • Study sites: 0 to 1
    • Study description expanded, about 30 words
    v3
  6. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Feb 2017 to Mar 10, 2017
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 single-chamber ventricular pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.
Trial Details
NCT Number NCT03039712
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