Status:
COMPLETED
AVEIR Remote Care System Non-Significant Risk Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Pacemaker
Cardiac Rhythm Disorder
Eligibility:
All Genders
18-100 years
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 i...
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 remot...
Eligibility Criteria
Inclusion
- 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
- 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 .
Key Trial Info
Start Date :
June 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06542133
Start Date
June 10 2024
End Date
August 30 2024
Last Update
April 10 2025
Active Locations (3)
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1
Arrhythmia Research Group
Jonesboro, Arkansas, United States, 72401
2
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
3
Premier Cardiology, Inc
Newport Beach, California, United States, 92663