Aveir VR Coverage With Evidence Development Post-Approval Study

Part of paid clinical trials in Sylmar, California.

Sponsor
Abbott Medical Devices
Study ID
NCT05336877
Status
Recruiting
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Conditions

  • Arrythmia
  • Bradycardia
  • Cardiac Pacemaker

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aveir VR Leadless Pacemaker System — DEVICE
    This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.
  • Single-Chamber Transvenous Pacemaker — DEVICE
    This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.

Study Details

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).

Key Dates

Start date
Jun 21, 2022
Status verified
Jul 2025
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
8,744 participants (estimated)

Arms

  • Arm: Device: Aveir VR Leadless Pacemaker System
    This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study.
  • Arm: Device: Single-Chamber Transvenous Pacemaker
    This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.

Primary Outcome Measure

Number of Subjects with Acute Device-Related Complications [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
AbbottSylmarCalifornia91342
Nicole Harbert
[email protected]
972-526-4841

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By research site
Abbott· Sylmar, CA

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