Aveir VR Coverage With Evidence Development Post-Approval Study

Launched by ABBOTT MEDICAL DEVICES · Apr 19, 2022

Keywords

ClinConnect Summary

The Aveir VR Coverage With Evidence Development study is a research trial that aims to understand the safety and long-term health effects of a new type of heart device called the Aveir Single-Chamber Leadless Pacemaker. This device is used for patients with heart rhythm problems like bradycardia, which is when the heart beats too slowly. The study is currently looking for participants who are Medicare patients and have received either the Aveir leadless pacemaker or a similar type of pacemaker from another manufacturer.

If you are a Medicare beneficiary who had one of these pacemakers implanted after the device was approved for use, you may be eligible to join the study. There are no specific exclusions, so most patients fitting this description can participate. Those who join can expect to help researchers gather important information about any complications that might arise and how well the device works over time. This study is crucial for ensuring that patients receive safe and effective treatments for their heart conditions.

Gender

ALL

Eligibility criteria

• • The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location
• Inclusion Criteria:
• • Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.
• • OR
• • Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date
• Exclusion Criteria:
• • None