clinical trial · NCT05270499
Aveir VR Real-World Evidence Post-Approval Study
Abbott Medical Devices·—·recruiting·n = 2,100
Cardiac PacemakerArrythmiaBradycardiaAveir VR Leadless Pacemaker System
brief 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.
started
Jun 21, 2022
primary completion
Feb 28, 2034
completion
Feb 28, 2034
last updated
Aug 20, 2024
detailed description
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.
official title
Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol