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Completed

NCT Number: NCT06542133

AVEIR Remote Care System Non-Significant Risk Study

The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.

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Key information

Conditions

Cardiac Pacemaker Arrhythmias, Cardiac Bradycardia Cardiac Rhythm Disorder Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arrhythmia Research Group, Jonesboro, Arkansas, United States

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About this study

To collect acute performance data about the AVEIR Remote Care System in participants implanted with a compatible dual or single chamber Aveir Leadless Pacemaker System by participants completing remote transmissions with the system

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject must provide written informed consent prior to any study-related procedure.
  • Subject is willing and has consented to study clinical procedure.
  • Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
  • Subject has an active, appropriately functioning Aveir leadless pacemaker system
  • Subject is willing to use the device

Exclusion criteria

  • Subject is unable to read/write at a sufficient level to provide informed consent.
  • Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.
  • Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation .

Treatment and study plan

AVEIR remote care system

Device

In-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients

Primary outcomes

  1. Successful end-to-end transmission performance metrics

    Time frame: The expected duration of each subject's participation is approximately 30 minutes for an in-clinic visit to complete two transmissions and thereafter an optional at-home transmission (expected duration 10-15 minutes)

    Successful transmission performance metrics of the AVEIR Remote Care System in approximately 32 subjects who have received an Aveir LP implanted system as part of their standard of care.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

AVEIR Remote Care System Data Collection Non-Significant Risk Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Apr 10, 2025

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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