RecruitingNot Applicable

Aveir DR Real-World Evidence Post-Approval Study

United States1,805 participantsStarted 2023-10-31

Plain-language summary

The purpose of this post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

Who can participate

Age range18 Years

SexALL

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Eligibility Criteria: * Implanted with an Aveir DR leadless pacemaker * Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for -30 days after implant, except in the case of death within the 30-day period * Ability to link with Medicare fee-for-service data

What they're measuring

Number of Subjects Free from Acute Aveir DR System-Related Complications

Timeframe: 30 Days

Number of Subjects Free from Chronic Aveir DR System-Related Complications

Timeframe: 5 Years

Trial details

NCT IDNCT05935007

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-01

Contact for this trial

Nicole Harbert

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

View on ClinicalTrials.gov More Cardiac Pacemaker trials