NCT05336877

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,744

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jun 2022Jan 2028

First Submitted

Initial submission to the registry

April 11, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 21, 2022

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

5.5 years

First QC Date

April 11, 2022

Last Update Submit

July 29, 2025

Conditions

Cardiac PacemakerArrythmiaBradycardia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Number of Subjects with Chronic Device-Related Complications

    6 months

  • Number of Subjects with a Device-Related Re-Intervention

    2 years

Study Arms (2)

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

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

Interventions

Aveir VR Leadless Pacemaker SystemDEVICE

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
Single-Chamber Transvenous PacemakerDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott

Sylmar, California, 91342, United States

RECRUITING

MeSH Terms

Conditions

Arrhythmias, CardiacBradycardia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Harbert

    Abbott

    STUDY DIRECTOR

Central Study Contacts

Nicole Harbert

CONTACT

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

Stephanie Delgado

CONTACT

stephanie.delgado1@abbott.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 20, 2022

Study Start

June 21, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)