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Recruiting NCT05336877

Aveir VR Coverage With Evidence Development Post-Approval Study

— Observational Cardiac Pacemaker Arrythmia Bradycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aveir VR Leadless Pacemaker System, Single-Chamber Transvenous Pacemaker.
Who it may be relevant to
Registry conditions: Cardiac Pacemaker, Arrythmia, Bradycardia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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.

Interventions

  • 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.

Primary outcome measures

  • Number of Subjects with Acute Device-Related Complications [Time frame: 30 days]
  • Number of Subjects Alive after 2 Years [Time frame: 2 years]
Secondary outcome measures (2)
  • Number of Subjects with Chronic Device-Related Complications [Time frame: 6 months]
  • Number of Subjects with a Device-Related Re-Intervention [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Abbott — Sylmar

Identifiers

NCT: NCT05336877 · ABT-CIP-10426

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗