AVEIR Remote Care System Non-Significant Risk Study

NCT06542133 | Completed FDA Device

• 1 other identifier: ABT-CIP-10527
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Cardiac Pacemaker; Cardiac Rhythm Disorder; Bradycardia

Outcome Measures

Primary Outcomes (1)

• Successful end-to-end transmission performance metrics

  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.

  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)

Study Arms (1)

Observational, Single Arm, Non Randomized

Aveir leadless pacemaker system patients

Device: AVEIR remote care system

Interventions

AVEIR remote care system DEVICE

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

Observational, Single Arm, Non Randomized

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

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 .

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Premier Cardiology, Inc

Newport Beach, California, 92663, United States

Location

Related Publications (1)

• Sundaram S, Chellappa N, Chaniary K, Lo M, Nair D, Banker R. Remote monitoring of leadless pacemakers using a novel conductive telemetry communication method. J Interv Card Electrophysiol. 2025 Jul 22. doi: 10.1007/s10840-025-02095-8. Online ahead of print.

  PMID: 40694240 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 7, 2024
• Study Start: June 10, 2024
• Primary Completion: July 12, 2024
• Study Completion: August 30, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)