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
This trial does not accept healthy volunteersQualifiers
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 population
The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir DR leadless pacemaker or a full-system dual-chamber transvenous pacemaker (from any manufacturer) in any US location.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Aveir AR Leadless Pacemaker
DeviceThis study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.
Single-chamber atrial transvenous pacemaker
DeviceThis study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study
Treatment groups
586 Participants
are divided into 2 treatment groupsGroup A: Aveir AR Leadless Pacemaker1 intervention
Group B: Single-Chamber Atrial Transvenous Pacemaker1 intervention
Trial outcomes
Primary outcomes
1
Acute device-related complication rate
Assess the acute (30-day) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant.
Time frame
30 days2
Two-year survival rate
Assess (2-year) survival rate of subjects implanted with an Aveir AR LP, compared to single chamber atrial transvenous pacemakers.
Time frame
2 yearsSecondary outcomes
1
Chronic complication rate
• To assess the chronic (6-month) complication rate of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve, occurring more than 30 days through six months post implant.
Time frame
6 months2
Device related re-intervention rate
• To assess (2-year) device-related re-intervention rates of the Aveir AR LP, compared to single chamber atrial transvenous pacemakers.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov