Aveir VR Coverage With Evidence Development Post-Approval Study (CED)

Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study

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).

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Arrythmia; Cardiac Pacemaker
• Intervention / Treatment: Device: Aveir VR Leadless Pacemaker System; Device: Single-Chamber Transvenous Pacemaker

Detailed Description

This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.

The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.

• Study Type: Observational
• Enrollment (Estimated): 8744

Contacts and Locations

• Study Contact: Name: Nicole Harbert; Phone Number: 972-526-4841; Email: Nicole.Harbert@abbott.com
• Study Contact Backup: Name: Stephanie Delgado; Email: stephanie.delgado1@abbott.com

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Recruiting
      • Abbott
      • Contact: Nicole Harbert; Phone Number: 972-526-4841; Email: Nicole.Harbert@abbott.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with Acute Device-Related Complications	Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.	30 days
Number of Subjects Alive after 2 Years	The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with Chronic Device-Related Complications	Rate of chronic complications in subjects implanted with Aveir VR LP compared with subjects implanted with a single-chamber ventricular transvenous pacemaker, from 31 days through six months post implant procedure. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve.	6 months
Number of Subjects with a Device-Related Re-Intervention	Rate of device-related re-intervention in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker, through 2 years post implant procedure.	2 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Nicole Harbert, Abbott

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: ABT-CIP-10426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes