Aveir VR Real-World Evidence Post-Approval Study

Launched by ABBOTT MEDICAL DEVICES · Feb 28, 2022

Keywords

ClinConnect Summary

The Aveir VR Real-World Evidence Post-Approval Study is looking at the long-term safety of a special type of heart device called the Aveir VR leadless pacemaker. This pacemaker helps people with heart rhythm problems, such as bradycardia, which means their heart beats too slowly. The study is currently recruiting participants to gather real-world information about how well this device works over time.

To be eligible for this study, participants need to have already received an Aveir VR leadless pacemaker and must have been enrolled in Medicare for at least 12 months before getting the device, continuing for 30 days after. This study is open to everyone aged 65 and older. Participants can expect to provide some health information and may have their data linked to Medicare records to help researchers understand the device's safety in everyday use. This study is important because it helps ensure that the pacemaker is safe for patients in the long run.

Gender

ALL

Eligibility criteria

• Eligibility Criteria:
• • Implanted with an Aveir VR 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