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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Abbott
Sylmar
California
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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