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NCT Number: NCT05935007

Aveir DR Real-World Evidence Post-Approval Study

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.

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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

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 DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.

Due to the RWE data collection methods used in this study, a central IRB approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Aveir DR Leadless Pacemaker System

Device

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

Primary outcomes

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

    Time frame: 30 Days

    Freedom from key acute complications through 30 days post implant procedure

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

    Time frame: 5 Years

    Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure

Secondary outcomes

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

    Time frame: 5 Years

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

  2. Number of Subjects with End of Device Service Events

    Time frame: 5 Years

    Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 5-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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Harbert

CONTACT

[email protected]

972-526-4841

Stephanie Delgado

CONTACT

[email protected]

818-493-3285

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jul 7, 2023
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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