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Clinical Trials in the USA / NCT05336877
Active, not recruiting Observational

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
2026-10-19

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
No
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)

FacilityCityRegionStatus
Abbott Sylmar California

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Other trials for the same condition

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System Recruiting
Aveir DR Real-World Evidence Post-Approval Study Recruiting
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED) Active, not recruiting
Chronic Evaluation of Novel Pacemaker System 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