AVEIR Remote Care System Data Collection Non-Significant Risk Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 32
- Locations
- 3
- Primary Endpoint
- Successful end-to-end transmission performance metrics
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 .
Outcomes
Primary Outcomes
Successful end-to-end transmission performance metrics
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported