|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P150035 / PAS001 |
| Date Original Protocol Accepted |
03/31/2022
|
| Date Current Protocol Accepted |
06/11/2026
|
| Study Name |
The Aveir VR RWE Study
|
| Device Name |
Aveir VR Leadless System
|
| Clinical Trial Number(s) |
NCT01700244
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the post-approval study (PAS) is to evaluate the long-term safety of the single-chamber Aveir Leadless Pacemaker device (aka VR LP) using real-world evidence (RWE) methods. The study utilizes a real-world evidence method merging multiple real-world datasets from Abbott and CMS to assess the Aveir VR LP safety in a large patient population. The study also assesses acute and chronic complications through 6 months in patients implanted with the AVEIR VR leadless pacemaker via internal jugular vein access.
|
| Study Population |
Adult (22 years and older)
|
| Sample Size |
2100
|
| Key Study Endpoints |
Primary Endpoints are:
- To assess freedom from key acute (30-day) complications post-implant procedure
- To assess freedom from key long-term (31 days through 10-year) complications post-implant procedure
Secondary Endpoints are:
- Complication rate of the Aveir VR LP for key individual acute and chronic complications
- Care of subjects at the end of device service
Descriptive Endpoints are:
- Rates of other procedure or device-related complications
- Survival at 10 years
- To assess device longevity
- Summarize study cohort demographics and comorbidities
- To assess device-device interaction
- To analyze effect of implanter experience with Aveir VR LP on safety performance
|
| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
Freedom from key acute complications through 30 days implant was 91.8% (95% CI: 90.8%-92.7%) for 3,427 devices.
Freedom from key chronic complications from 31 days to 10 years post implant was evaluated through 36-months based on data available through the data
cut-off rate for this 48-month progress report. The event-free survival rate was 99.2% at 36-months post implant for 3,210 devices.
Subjects continue to be followed within the study so that the follow-up period will be updated as the study progresses.
Subject enrollment is closed for this study. Enrolled subjects include patients with prior Cardiovascular Implantable Electronic Devices (CIED) as well as de
novo patients (patients with no prior CIED implants).
|
| Actual Number of Patients Enrolled |
Actual number of patients enrolled is 3,418 (3,427 devices)
|
| Actual Number of Sites Enrolled |
Actual number of sites enrolled is 511
|
| Patient Follow-up Rate |
N/A
|
