Evaluating the Aveir Atrial Leadless Pacemaker for Medicare Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the complications and long-term health outcomes associated with the Aveir Atrial Leadless Pacemaker device among Medicare beneficiaries. By utilizing real-world evidence methods, the study merges multiple datasets from Abbott and the Center for Medicare Services to evaluate health outcomes for patients implanted with either the Aveir AR LP or a single-chamber atrial transvenous pacemaker. The study does not require individual patient consent due to an approved informed consent waiver, allowing for a broader analysis of real-world data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.

   OR
2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date

Exclusion Criteria:

* None

Where it's running

• Abbott
  Sylmar, California, United States Recruiting

Study contacts

• Study coordinator: Nicole Harbert
• Email: nicole.harbert@abbott.com
• Phone: 972-526-4841

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.