Aveir VR Coverage With Evidence Development Post-Approval Study

NCT05336877 · tracked via the Priya Life Science USA tracker

Sponsor

Abbott Medical Devices

Phase

Observational

Started

2022-06-21

Last updated

2025-07-31

Condition(s) studied

Cardiac PacemakerArrythmiaBradycardia

Investigational drug(s) / intervention(s)

Aveir VR Leadless Pacemaker SystemSingle-Chamber Transvenous Pacemaker

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.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Number of Subjects with Acute Device-Related Complications — 30 days
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.
Number of Subjects Alive after 2 Years — 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.

Trial sites (1)

Facility	City	Region	Status
Abbott	Sylmar	California	Recruiting

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Other trials for the same condition

Aveir VR Real-World Evidence Post-Approval Study Active, not recruiting

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System Recruiting

Cardiac Implantable Electronic Device (CIED) Research Study Active, not recruiting

Micra Transcatheter Pacing System Post-Approval Registry Active, not recruiting

Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05336877 on ClinicalTrials.gov ↗ ← All trials in the USA