Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational, Single Arm, Non Randomized | Aveir leadless pacemaker system patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVEIR remote care system | Device | In-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Primary care clinic
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | United States | ||
| Arkansas Heart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40694240 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Premier Cardiology, Inc | Newport Beach | California | 92663 | United States |