NCT06542133

AVEIR Remote Care System Non-Significant Risk Study

AVEIR Remote Care System Data Collection Non-Significant Risk Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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

Conditions

• Cardiac Pacemaker
• Cardiac Rhythm Disorder
• Bradycardia

Interventions

Type	Name	Description
DEVICE	AVEIR remote care system	In-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients

Timeline

• Start date: 2024-06-10
• Primary completion: 2024-07-12
• Completion: 2024-08-30
• First posted: 2024-08-07
• Last updated: 2025-04-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study