Aveir AR Coverage With Evidence Development (CED) Study

Launched by ABBOTT MEDICAL DEVICES · Oct 20, 2023

Keywords

ClinConnect Summary

The Aveir AR Coverage With Evidence Development (CED) Study is a clinical trial designed to learn more about the safety and effectiveness of a new type of heart device called the Aveir Atrial Leadless Pacemaker. This small device helps people with heart rhythm problems, like bradycardia, which is when the heart beats too slowly. The study aims to find out how well the device works over time and what potential complications may arise after it is implanted.

To participate in this study, you must be a Medicare beneficiary who has received an Aveir AR leadless pacemaker or a traditional single-chamber pacemaker since the device was approved for use. There are no specific exclusions, meaning most people who meet the criteria can join. If you take part, you can expect to be monitored over time to see how the device performs and how it affects your health. This trial is currently recruiting participants, and your involvement could help improve treatment options for others with similar heart conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • OR
• • 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
• Exclusion Criteria:
• • None