Aveir AR Coverage With Evidence Development (CED) Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).
Eligibility criteria
Qualifiers
Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study.
Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date
Disqualifiers
None
Trial design
Treatments tested in this trial
- Aveir AR Leadless Pacemaker
- Single-chamber atrial transvenous pacemaker
Treatment groups
586 Participants
are divided into 2 treatment groupsLocations
1Abbott91342, SylmarCalifornia, United States
Sponsors and collaborators
Abbott Medical Devices
Lead sponsor
Source ClinicalTrials.gov