Arrythmia, Bradycardia, Cardiac Pacemaker
Conditions
Keywords
bradycardia, sick sinus rhythm, pacemaker, av block, Vasovagal Syncope
Brief summary
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
Detailed description
This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.
Interventions
This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention will be conducted in this study.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: * Implanted with an Aveir VR leadless pacemaker * Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period * Ability to link with Medicare fee-for-service data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Free from Acute Aveir VR System-Related Complications | 30 days | Freedom from complications through 30 days post implant procedure |
| Number of Subjects Free from Chronic Aveir VR System-Related Complications | 10 Years | Freedom from Complications from 31 days through 10 years post implant procedure procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications | 10 Years | Complication rate of the Aveir VR leadless pacemaker for individual acute and chronic complications |
| Number of Subjects with End of Device Service Events | 10 Years | Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 10-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event. |
Countries
United States
Contacts
STUDY_DIRECTORNicole Harbert
Abbott
Outcome results
None listed