AVEIR Remote Care System Non-Significant Risk Study

Completed

• Conditions: Bradycardia; Cardiac Rhythm Disorder; Cardiac Pacemaker
• Interventions: Device: AVEIR remote care system

• Registration Number: NCT06542133
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2024-06-10
• Primary Completion: 2024-07-12
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-08-02
• Study First Posted: 2024-08-07
• Study Completion: 2024-08-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 .

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational, Single Arm, Non Randomized	AVEIR remote care system	Aveir leadless pacemaker system patients

Primary Outcome Measures

Name	Time	Method
Successful end-to-end transmission performance metrics	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.

Trial Locations

Locations (3)

Arrhythmia Research Group; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Premier Cardiology, Inc; 🇺🇸 Newport Beach, California, United States