Aveir VR Real-World Evidence Post-Approval Study

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker
• Intervention / Treatment: Device: Aveir VR Leadless Pacemaker System

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.

• Study Type: Observational
• Enrollment (Actual): 3427

Contacts and Locations

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Abbott

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients who had an implant of the Aveir VR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Arm; Non randomized	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Free from Acute Aveir VR System-Related Complications	Freedom from complications through 30 days post implant procedure	30 days
Number of Subjects Free from Chronic Aveir VR System-Related Complications	Freedom from Complications from 31 days through 10 years post implant procedure procedure	10 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications	Complication rate of the Aveir VR leadless pacemaker for individual acute and chronic complications	10 Years
Number of Subjects with End of Device Service Events	Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 10-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event.	10 Years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Nicole Harbert, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): September 30, 2034
• Study Completion (Estimated): September 30, 2034

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: pacemaker; av block; bradycardia; Vasovagal Syncope; sick sinus rhythm
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Neurobehavioral Manifestations; Heart Block; Primary Dysautonomias; Autonomic Nervous System Diseases; Orthostatic Intolerance; Consciousness Disorders; Unconsciousness; Syncope; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Atrioventricular Block; Bradycardia; Arrhythmias, Cardiac; Syncope, Vasovagal
• Other Study ID Numbers: ABT-CIP-10418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes