Aveir DR Real-World Evidence Post-Approval Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices

About this trial

The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Aveir DR Leadless Pacemaker System

Treatment groups

1,805 Participants
are divided into 1 treatment group

Sponsors and collaborators