Recruiting

Aveir VR LP

Sponsor:

Abbott Medical Devices

Code:

NCT05336877

Conditions

Cardiac Pacemaker

Arrythmia

Bradycardia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aveir VR Leadless Pacemaker System

Single-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 single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

Conditions

Cardiac Pacemaker

Arrythmia

Bradycardia

Study ID

NCT05336877

Start date

Jun 21, 2022

Status verified date

Jul, 2025

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

Inclusion Criteria:

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

OR

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

Exclusion Criteria:

None

Study Design

Enrollment

8744 participants

Anticipated

Interventions and Outcome Measures

Arms

Device: Aveir VR Leadless Pacemaker System

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

Device: Single-Chamber Transvenous Pacemaker

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

Interventions

Aveir VR Leadless Pacemaker System

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

Single-Chamber Transvenous Pacemaker

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

Primary outcome measure

  • Number of Subjects with Acute Device-Related Complications [ Time Frame: 30 days ]
  • Number of Subjects Alive after 2 Years [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Nicole Harbert

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

Stephanie Delgado

stephanie.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

Jul 31, 2025

Last verified

Jul, 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 2025-07-31.