RecruitingNCT06100770

Aveir AR Coverage With Evidence Development (CED) Study

Sponsor

Abbott Medical Devices

Enrollment

586 participants

Start Date

Jan 18, 2024

Study Type

OBSERVATIONAL

Conditions

Arrhythmia Bradycardia Cardiac Pacemaker

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Aveir AR Leadless Pacemaker and a medical device called Single-chamber atrial transvenous pacemaker for people with arrhythmia, bradycardia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAveir 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.

DEVICESingle-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