Aveir DR Real-World Evidence Post-Approval Study

NCT05935007 | Recruiting FDA Device

• 1 other identifier: ABT-CIP-10454
• Study Type: observational
• Target: 1,805
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Pacemaker; Arrythmia; Bradycardia

Keywords

bradycardia; sick sinus rhythm; pacemaker; av block; vasovagal syncope

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related

  5 Years

• Number of Subjects with End of Device Service Events

  5 Years

Study Arms (1)

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

Interventions

Aveir DR Leadless Pacemaker System 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Abbott

Sylmar, California, 91342, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Bradycardia; Atrioventricular Block; Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Nicole Harbert

  Abbott

  STUDY DIRECTOR

Central Study Contacts

Nicole Harbert

CONTACT

972-526-4841; nicole.harbert@abbott.com

Stephanie Delgado

CONTACT

818-493-3285; Stephanie.delgado1@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: July 7, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)