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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventions | Device: Aveir DR Leadless Pacemaker System 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aveir DR Leadless Pacemaker System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Free from Acute Aveir DR System-Related Complications | Freedom from key acute complications through 30 days post implant procedure | 30 Days |
| Number of Subjects Free from Chronic Aveir DR System-Related Complications | Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure | 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related | Complication rate of the Aveir DR leadless pacemaker for key individual acute and chronic complications | 5 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 DR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Harbert | Contact | 972-526-4841 | nicole.harbert@abbott.com | |
| Stephanie Delgado | Contact | 818-493-3285 | Stephanie.delgado1@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Harbert | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott | Recruiting | 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 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.
| 5 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 |