Aveir DR 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

1805 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-31

Study Completion Date

2030-01-31

Brief Summary

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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.

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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 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.

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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Interventions

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.

Aveir DR Leadless Pacemaker System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No