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 dual-chamber Aveir DR 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 DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA. Due to the RWE data collection methods used in this study, a central IRB approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.
Interventions
This study will utilize real-world data from patients implanted with the Aveir DR 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 DR 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 DR System-Related Complications | 30 Days | Freedom from key acute complications through 30 days post implant procedure |
| Number of Subjects Free from Chronic Aveir DR System-Related Complications | 5 Years | Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related | 5 Years | Complication rate of the Aveir DR leadless pacemaker for key individual acute and chronic complications |
| Number of Subjects with End of Device Service Events | 5 Years | Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 5-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
CONTACTNicole Harbert
CONTACTStephanie Delgado
STUDY_DIRECTORNicole Harbert
Abbott
Outcome results
None listed