Aveir AR Coverage With Evidence Development (CED) Study

Description

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

Cardiac Pacemaker, Arrhythmia, Bradycardia

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Study Overview

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Study Details

Study overview

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).

Aveir AR Coverage With Evidence Development (CED) Study

Aveir AR Coverage With Evidence Development (CED) Study

Condition
Cardiac Pacemaker
Intervention / Treatment

-

Contacts and Locations

Sylmar

Abbott, Sylmar, California, United States, 91342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study.
  • 2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date
  • * None

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Nicole Harbert, STUDY_DIRECTOR, Abbott

Study Record Dates

2031-01