AVEIR DR Coverage With Evidence Development (CED) Study

StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised
    • Eligibility criteria expanded, about 1 word
  2. Primary completion date: Oct 2025 to May 2029
    • Study completion date: Oct 2025 to May 2030
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2023 to Oct 31, 2023
    v2
  4. Study First Submitted
  • 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.
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).
Trial Details
NCT Number NCT05932602
Lead Sponsor Abbott Medical Devices
Conditions
(from sponsor)		 Cardiac Pacemaker, Arrythmia, Bradycardia
Related terms Arrhythmias, Cardiac, Atrioventricular Block, Bradycardia
Enrollment 2,812 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov