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Aveir AR Coverage With Evidence Development (CED) Study

RECRUITINGSponsored by Abbott Medical Devices
Actively Recruiting
SponsorAbbott Medical Devices
Started2024-01-18
Est. completion2030-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

Summary

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

ArrhythmiaBradycardiaCardiac PacemakerHeart Disease

Locations1 site

Abbott
Sylmar, California, 91342
Nicole Harbert972-526-4841

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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