Recruiting

Aveir AR

Sponsor:

Abbott Medical Devices

Code:

NCT06100770

Conditions

Cardiac Pacemaker

Arrhythmia

Bradycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aveir AR Leadless Pacemaker

Single-chamber atrial 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 single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

Conditions

Cardiac Pacemaker

Arrhythmia

Bradycardia

Study ID

NCT06100770

Start date

Jan 18, 2024

Status verified date

Apr, 2025

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

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

Exclusion Criteria:

  • None

Study Design

Enrollment

586 participants

Anticipated

Interventions and Outcome Measures

Arms

Aveir AR Leadless Pacemaker

This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.

Single-Chamber Atrial Transvenous Pacemaker

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

Interventions

Aveir AR Leadless Pacemaker

This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.

Single-chamber atrial transvenous pacemaker

This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP 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

972-526-4841

More Information

Sponsor

Abbott Medical Devices

Last update posted

Apr 4, 2025

Last verified

Apr, 2025

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 2025-04-04.