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OpenTrials
Active, Not Recruiting

NCT Number: NCT05270499

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Pacemaker Arrhythmias, Cardiac Arrythmia Atrioventricular Block Autonomic Nervous System Diseases Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Consciousness Disorders Heart Block Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Syncope, Vasovagal Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott

Sylmar, California, 91342, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aveir VR Leadless Pacemaker System

Device

This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention will be conducted in this study.

Primary outcomes

  1. Number of Subjects Free from Acute Aveir VR System-Related Complications

    Time frame: 30 days

    Freedom from complications through 30 days post implant procedure

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

    Time frame: 10 Years

    Freedom from Complications from 31 days through 10 years post implant procedure procedure

Secondary outcomes

  1. Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications

    Time frame: 10 Years

    Complication rate of the Aveir VR leadless pacemaker for individual acute and chronic complications

  2. Number of Subjects with End of Device Service Events

    Time frame: 10 Years

    Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 10-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study

Important dates

Study start
2022
Primary completion
2034
Study completion
2034
First posted
Mar 8, 2022
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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