Recruiting

AVEIR

Sponsor:

Abbott Medical Devices

Code:

NCT05932602

Conditions

Cardiac Pacemaker

Arrythmia

Bradycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aveir DR Leadless Pacemaker System

Dual Chamber Transvenous Pacemaker

Study Details

Brief summary:

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the dual chamber Aveir Leadless Pacemaker device (aka Aveir™ DR LP system).

Conditions

Cardiac Pacemaker

Arrythmia

Bradycardia

Study ID

NCT05932602

Start date

Oct 31, 2023

Status verified date

Apr, 2025

Completion date

May, 2030

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Medicare beneficiaries implanted with an Aveir DR leadless pacemaker on or after the study start date (i.e., the date of Aveir DR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) dual-chamber transvenous pacemaker on or after the study start date

Exclusion Criteria:

None

Study Design

Enrollment

2812 participants

Anticipated

Interventions and Outcome Measures

Arms

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 is required in this study.

Dual Chamber Transvenous Pacemaker

This study will utilize real-world data from patients implanted with a dual-chamber transvenous pacemaker as a comparator to the Aveir DR LP system study arm. No device intervention is required 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 is required in this study.

Dual Chamber Transvenous Pacemaker

This study will utilize real-world data from patients implanted with a dual-chamber transvenous pacemaker as a comparator to the Aveir DR LP system study arm. No device intervention is required in this study.

Primary outcome measure

  • Acute device related complication rate [ Time Frame: 30 days ]
  • Two-year survival rate [ Time Frame: 2 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

Apr 6, 2025

Last verified

Apr, 2025

Keywords

  • dual chamber
  • sick sinus rhythm
  • pacemaker
  • AV Block

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 2025-04-06.