Aveir DR Real-World Evidence Post-Approval Study

Aveir Dual-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 dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker
• Intervention / Treatment: Device: Aveir DR 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 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.

• Study Type: Observational
• Enrollment (Estimated): 1805

Contacts and Locations

• Study Contact: Name: Nicole Harbert; Phone Number: 972-526-4841; Email: Nicole.Harbert@abbott.com
• Study Contact Backup: Name: Stephanie Delgado; Phone Number: 818-493-3285; Email: Stephanie.delgado1@abbott.com

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Recruiting
      • Abbott
      • Contact: Nicole Harbert; Phone Number: 972-526-4841; Email: Nicole.Harbert@abbott.com

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 DR 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 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Free from Acute Aveir DR System-Related Complications	Freedom from key acute complications through 30 days post implant procedure	30 Days
Number of Subjects Free from Chronic Aveir DR System-Related Complications	Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related	Complication rate of the Aveir DR leadless pacemaker for key individual acute and chronic complications	5 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 5-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.	5 Years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 7, 2023

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-10454

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