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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P150035 S003/ PAS001 |
| Date Original Protocol Accepted |
06/29/2023
|
| Date Current Protocol Accepted |
11/22/2024
|
| Study Name |
Aveir DR Real-World Evidence Study
|
| Device Name |
Aveir DR Leadless System
|
| Clinical Trial Number(s) |
NCT05252702
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the post-approval study (PAS) is to evaluate the long-term safety of the dual-chamber Aveir Leadless Pacemaker device (aka DR 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 DR LP safety in a large patient population.
|
| Study Population |
All de novo patients implanted with the Aveir DR LP who successfully link to Medicare FFS data will be included in the analysis, starting at market approval and continuing for approximately one year or longer, if necessary, to include a minimum of 1,805 subjects. Patients implanted with an Aveir atrial LP only (i.e., without a ventricular LP) will be analyzed in additional analysis and not in the primary and secondary analyses.
|
| Sample Size |
1805
|
| Key Study Endpoints |
Primary Endpoints:
1. Acute complications through 30 days post implant procedure
2. Freedom from chronic complications from 31 days through 5 years post implant procedure
Secondary Endpoints:
1. Complication rate of the Aveir DR LP for key individual acute and chronic complications
2. Care of subjects at the end of device service
Descriptive Endpoints and Analyses:
1. Rates of other procedure-related acute complications
2. Survival at 5 years
3. Device longevity
4. Device longevity by device (atrial, ventricular)
5. Acute complications by device (atrial, ventricular)
6. Chronic complications by device (atrial, ventricular)
Additional analyses include:
1. Cohort demographics and comorbidities
2. Device-device interaction
3. Effect of implanter experience with DR leadless pacemakers
4. Acute and chronic complications in patients with an atrial LP only
5. Battery performance
6. i2i performance
7. Acute and chronic complications in all Aveir patients (de novo and non de novo)
|
| Follow-up Visits and Length of Follow-up |
The study completion is 5 years after the final implant.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
The key acute complication rate through 30 days post implant was 7.6% (95% CI 5.8%-9.8%) as of the data cut-off date for 760 implants in the primary de novo analysis group. The primary de novo cohort includes subjects implanted with both AVEIR DR devices (atrial and ventricular LPs) that meet the de novo criteria defined as subjects who do not have evidence of a prior Cardiac Implantable Electronic Device (CIED). A CIED includes a leadless single-chamber pacemaker, transvenous single-chamber pacemaker, dual-chamber leadless pacemaker, dual-chamber transvenous pacemaker, implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy pacemaker (CRT-P) or defibrillator (CRT-D).
Effectiveness Results:
Freedom from key chronic complications from 31 days to 5 years post implant was evaluated through 13-months based on data available through the data cut-off date for this 24-month report. The event-free survival rate was 98.3% at 13-months post implant for 760 implants in the primary de novo analysis group.
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| Actual Number of Patients Enrolled |
1334
|
| Actual Number of Sites Enrolled |
226 enrolled
|
| Patient Follow-up Rate |
N/A
|
