Aveir AR Coverage With Evidence Development (CED) Study

Part of paid clinical trials in Sylmar, California.

Sponsor
Abbott Medical Devices
Study ID
NCT06100770
Status
Recruiting
Apply to this trial

Conditions

  • Arrhythmia
  • Bradycardia
  • Cardiac Pacemaker

Eligibility Criteria

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

Interventions

  • Aveir AR Leadless Pacemaker — DEVICE
    This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.
  • Single-chamber atrial transvenous pacemaker — DEVICE
    This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP 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 Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

Key Dates

Start date
Jan 18, 2024
Status verified
Apr 2025
Primary completion
Jan 31, 2030
Completion
Jan 31, 2031

Study Design

Enrollment
586 participants (estimated)

Arms

  • Arm: Aveir AR Leadless Pacemaker
    This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.
  • Arm: Single-Chamber Atrial Transvenous Pacemaker
    This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP 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
972-526-4841

Find similar trials in Sylmar, CA

By research site
Abbott· Sylmar, CA

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