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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
View on ClinicalTrials.gov →
NCT06100770
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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Actively Recruiting
SponsorAbbott Medical Devices
Started2024-01-18
Est. completion2030-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06100770