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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Non randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aveir VR Leadless Pacemaker System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Free from Acute Aveir VR System-Related Complications | Freedom from complications through 30 days post implant procedure | 30 days |
| Number of Subjects Free from Chronic Aveir VR System-Related Complications | Freedom from Complications from 31 days through 10 years post implant procedure procedure | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications | Complication rate of the Aveir VR leadless pacemaker for individual acute and chronic complications | 10 Years |
| Number of Subjects with End of Device Service Events |
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Eligibility Criteria:
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All patients who had an implant of the Aveir VR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Harbert | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott | Sylmar | California | 91342 | United States |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001919 | Bradycardia |
| D054537 | Atrioventricular Block |
| D019462 | Syncope, Vasovagal |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 10 Years |
| D006327 | Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |