Aveir DR Leadless Pacemaker Study for Medicare Beneficiaries

This study is looking at how well the Aveir DR Leadless Pacemaker System works and its long-term health effects compared to a traditional dual-chamber pacemaker. Researchers will use existing health information from Medicare patients who have received either the Aveir DR Leadless Pacemaker or a standard dual-chamber pacemaker. The study aims to understand the rate of device-related complications within 30 days and how long patients survive after two years. You could be included if you are a Medicare beneficiary who received either of these pacemakers on or after the study's start date. This study uses real-world data, so you won't need to do anything extra.

Study design
This is an observational study that will look at health data from approximately 2,812 Medicare beneficiaries. It compares patients who received the Aveir DR Leadless Pacemaker to those who received a dual-chamber transvenous pacemaker.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track acute device-related complications for 30 days and patient survival for two years.

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NCT05932602

AVEIR DR Coverage With Evidence Development (CED) Study

Recruiting
Not specifiedAges 18+Observational
Abbott Medical Devices
~2,812 participants
Updated 2025-04-06 on ClinicalTrials.gov
What's tested:Aveir DR Leadless Pacemaker SystemDual Chamber Transvenous Pacemaker

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute device related complication rate
Measured over 30 days
+1 more outcome measured
Cardiac Pacemaker
Arrythmia
Bradycardia
1 sites across 1 states
California1
  • Nicole Harbert · STUDY_DIRECTOR · Abbott

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Eligibility criteria

Inclusion

Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.
  • Acute device related complication rate30 days

    Assess the acute (30-day) complication rate of the Aveir DR LP, compared to dual chamber transvenous pacemakers. An acute complication is defined as a peri-procedural, device-related adverse event occurring within 30 days post-implant.

  • Two-year survival rate2 years

    Assess (2-year) survival rate of subjects implanted with an Aveir DR LP, compared to dual chamber transvenous pacemakers.