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Aveir AR Coverage With Evidence Development (CED) Study

NCT06100770 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 586

Last updated 2025-04-04

No results posted yet for this study

Summary

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).

Conditions

Interventions

DEVICE

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.

DEVICE

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Nicole Harbert · Abbott

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2030-01-31
Completion
2031-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06100770 on ClinicalTrials.gov