Recruiting

Aveir DR

Sponsor:

Abbott Medical Devices

Code:

NCT05935007

Conditions

Cardiac Pacemaker

Arrythmia

Bradycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aveir DR Leadless Pacemaker System

Study Details

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

Study ID

NCT05935007

Start date

Oct 31, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1805 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Number of Subjects Free from Acute Aveir DR System-Related Complications [ Time Frame: 30 Days ]
  • Number of Subjects Free from Chronic Aveir DR System-Related Complications [ Time Frame: 5 Years ]

Central Contacts and Locations

Central contacts

Nicole Harbert

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

Stephanie Delgado

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

Locations

Abbott

Recruiting

Sylmar, California, United States, 91342

Contacts

Nicole Harbert

972-526-4841Nicole.Harbert@abbott.com

More Information

Sponsor

Abbott Medical Devices

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-05-20.