AVEIR DR Coverage With Evidence Development (CED) Study

Part of paid clinical trials in Sylmar, California.

Sponsor
Abbott Medical Devices
Study ID
NCT05932602
Status
Recruiting
Apply to this trial

Conditions

  • Arrythmia
  • Bradycardia
  • Cardiac Pacemaker

Eligibility Criteria

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

Interventions

  • Aveir DR Leadless Pacemaker System — DEVICE
    This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention is required in this study.
  • Dual Chamber Transvenous Pacemaker — DEVICE
    This study will utilize real-world data from patients implanted with a dual-chamber transvenous pacemaker as a comparator to the Aveir DR 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 dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Key Dates

Start date
Oct 31, 2023
Status verified
Apr 2025
Primary completion
May 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
2,812 participants (estimated)

Arms

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

Primary Outcome Measure

Acute device related complication rate [ Time Frame: 30 days ]

Central Contacts

Locations (1)

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

Find similar trials in Sylmar, CA

By research site
Abbott· Sylmar, CA

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