AVEIR Remote Care System Non-Significant Risk Study

Abbott

Status: Completed

Conditions: Bradycardia; Cardiac Rhythm Disorder; Cardiac Pacemaker

Treatments: Device: AVEIR remote care system

Study type: Observational

Funder types: Industry

Identifiers

NCT06542133

ABT-CIP-10527

Details and patient eligibility

About

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.

Full 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

Enrollment: 32 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

32 participants in 1 patient group

Observational, Single Arm, Non Randomized

Description:

Aveir leadless pacemaker system patients

Treatment:

Device: AVEIR remote care system