Aveir DR Real-World Evidence Post-Approval Study

Launched by ABBOTT MEDICAL DEVICES · Jul 5, 2023

Keywords

ClinConnect Summary

The Aveir DR Real-World Evidence Post-Approval Study is looking into the long-term safety of the Aveir DR leadless pacemaker, which is a small device used to help regulate heart rhythms in patients with conditions like arrhythmia or bradycardia. Since this is a post-approval study, it aims to gather real-life information about how well the pacemaker works outside of a clinical trial setting. The study is currently recruiting participants, and anyone aged 65 to 74 who has received an Aveir DR pacemaker and has been enrolled in Medicare for at least 12 months before the implant (and 30 days after, unless they passed away within that time) may be eligible to join.

Participants in this study can expect to share their experiences and health information to help researchers better understand the long-term effects of the pacemaker. It's important to note that this study uses data from Medicare, so being able to access this information is necessary for participation. This trial aims to ensure that the Aveir DR pacemaker remains safe and effective for individuals who need it, contributing to better heart health in the community.

Gender

ALL

Eligibility criteria

• Eligibility Criteria:
• • Implanted with an Aveir DR leadless pacemaker
• • Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period
• • Ability to link with Medicare fee-for-service data