RecruitingNCT05270499

Aveir VR Real-World Evidence Post-Approval Study

Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study


Sponsor

Abbott Medical Devices

Enrollment

2,100 participants

Start Date

Jun 21, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on patients who have received the Aveir VR leadless pacemaker — a small, self-contained pacemaker implanted directly into the heart without leads (wires). The study uses Medicare claims data to track long-term outcomes. You may be eligible if: - You have already been implanted with an Aveir VR leadless pacemaker - You are enrolled in Medicare Part A and Part B continuously for 12 months before and 30 days after the implant - Your data can be linked with Medicare fee-for-service records You may NOT be eligible if: - You do not have the required continuous Medicare enrollment - Your data cannot be linked to Medicare fee-for-service records Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAveir VR Leadless Pacemaker System

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.


Locations(1)

Abbott

Sylmar, California, United States

View Full Details on ClinicalTrials.gov

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NCT05270499


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