RecruitingNCT05932602

AVEIR DR Coverage With Evidence Development (CED) Study

The AVEIR DR Coverage With Evidence Development (DRIVE) Study

Sponsor

Abbott Medical Devices

Enrollment

2,812 participants

Start Date

Oct 31, 2023

Study Type

OBSERVATIONAL

Conditions

Arrythmia 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 dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Aveir DR Leadless Pacemaker System and a medical device called Dual Chamber Transvenous Pacemaker for people with arrythmia, 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 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.

DEVICEDual 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.