Aveir VR Coverage With Evidence Development Post-Approval Study

Study acronym: CED
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
  2. Site contact updatedv8
  3. 3 versions Re-verified since Sep 20, 2022, no change to tracked fieldsv5-v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2022 to Jun 21, 2022
    v4
  5. Phase: Not applicable to Not specifiedv3
  6. Lead sponsor: [Redacted] to Abbott Medical Devicesv2 Show 4 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary and study completion dates: Jan 1, 2028
    • Start date: Jul 1, 2022
    • Study title shortened, about 5 words
  7. 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 single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
Trial Details
NCT Number NCT05336877
Lead Sponsor Abbott Medical Devices
Conditions
(from sponsor)		 Cardiac Pacemaker, Arrythmia, Bradycardia
Related terms Arrhythmias, Cardiac, Bradycardia
Enrollment 8,744 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov