AVEIR Remote Care System Non-Significant Risk Study

Completed

Conditions studied: Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia

In brief

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.

Key facts

Study ID

NCT06542133

Run by

Abbott Medical Devices

People needed

32

Starts

2024-06-10

Expected to finish

2024-08-30

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 .

Where it is running

• Arrhythmia Research Group — Jonesboro, Arkansas, United States
• Arkansas Heart Hospital — Little Rock, Arkansas, United States
• Premier Cardiology, Inc — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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