AVEIR DR Coverage With Evidence Development (CED) Study

Launched by ABBOTT MEDICAL DEVICES · Jul 5, 2023

Keywords

ClinConnect Summary

The AVEIR DR Coverage With Evidence Development (CED) Study is a clinical trial designed to learn more about the safety and long-term health effects of a special type of heart device called the Aveir Leadless Pacemaker. This device helps people with heart conditions, such as arrhythmia (irregular heartbeat) and bradycardia (a slow heartbeat), by regulating their heart rhythm. The study is currently looking for participants who are Medicare beneficiaries and have received the Aveir DR pacemaker or a traditional dual-chamber pacemaker after the device was approved for use.

If you or a family member is between the ages of 65 and 74 and has had one of these pacemakers implanted, you may be eligible to join the study. Participants will be monitored for any complications and overall health over time. There are no specific exclusions for the study, making it open to a broad range of individuals who meet the criteria. This research is important as it aims to ensure that this new pacemaker device is safe and effective for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.
• • OR
• • Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date
• Exclusion Criteria:
• • None