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 groupLocations
1Abbott91342, SylmarCalifornia, United States
Sponsors and collaborators
Abbott Medical Devices
Lead sponsor
Source ClinicalTrials.gov