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AVEIR DR Coverage With Evidence Development (CED) Study
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).
Conditions:
🦠 Cardiac Pacemaker 🦠 Arrythmia 🦠 Bradycardia
🗓️ Study Start (Actual) 31 October 2023
🗓️ Primary Completion (Estimated) October 2025
✅ Study Completion (Estimated) October 2025
👥 Enrollment (Estimated) 2812
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Sylmar, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.
    • OR
    • Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date

    Exclusion Criteria:

    • None
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 23 June 2023
  • First Submitted that Met QC Criteria 5 July 2023
  • First Posted 6 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 November 2023
  • Last Update Posted 3 November 2023
  • Last Verified October 2023
I'm interested ...!!