Aveir VR Real-World Evidence Post-Approval Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-21

Study Completion Date

2034-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Pacemaker Arrythmia Bradycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

Non randomized

Aveir VR Leadless Pacemaker System

Intervention Type DEVICE

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.

Interventions

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Aveir 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Eligibility Criteria:

* Implanted with an Aveir VR 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No