An observational study in Cardiac Pacemaker, Arrythmia and Bradycardia, sponsored by Abbott Medical Devices. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 1,805 is above the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Compared within Bradycardia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Arrhythmias, Cardiac. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
Eligibility Criteria:
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.
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.
Number of Subjects Free from Acute Aveir DR System-Related Complications
Freedom from key acute complications through 30 days post implant procedure
Time frame: 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
Time frame: 5 Years
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
Time frame: 5 Years
Number of Subjects with End of Device Service Events
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.
Time frame: 5 Years
Plan to share: No
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