RecruitingNot Applicable

AVEIR DR Coverage With Evidence Development (CED) Study

United States2,812 participantsStarted 2023-10-31

Plain-language summary

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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. OR Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date Exclusion Criteria: None

What they're measuring

Acute device related complication rate

Timeframe: 30 days

Two-year survival rate

Timeframe: 2 years

Trial details

NCT IDNCT05932602

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-05

Contact for this trial

Nicole Harbert

972-526-4841 nicole.harbert@abbott.com

View on ClinicalTrials.gov More Cardiac Pacemaker trials