RecruitingNot Applicable

Aveir VR Real-World Evidence Post-Approval Study

United States2,100 participantsStarted 2022-06-21

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Eligibility Criteria: * Implanted with an Aveir VR 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 VR System-Related Complications

Timeframe: 30 days

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

Timeframe: 10 Years

Trial details

NCT IDNCT05270499

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2034-02-28

Contact for this trial

Nicole Harbert

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

View on ClinicalTrials.gov More Cardiac Pacemaker trials