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RECRUITINGNCT05270499

Aveir VR Real-World Evidence Post-Approval Study

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.

Lead sponsor: Abbott Medical Devices•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Nicole Harbert

CONTACT

972-526-4841 [email protected]

Stephanie Delgado

CONTACT

[email protected]

Sponsors

Lead Sponsor

Abbott Medical Devices

This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 20, 2024Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment2,100

Start dateJun 2022

Last updatedAug 20, 2024

Condition

Cardiac Pacemaker Arrythmia Bradycardia

Locations shown

Abbott

Sylmar, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2024Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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