Menu
Recruiting NCT06100770

Aveir AR Coverage With Evidence Development (CED) Study

— Observational Cardiac Pacemaker Arrhythmia 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 AR Leadless Pacemaker, Single-chamber atrial transvenous pacemaker.
Who it may be relevant to
Registry conditions: Cardiac Pacemaker, Arrhythmia, 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 →

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 Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

Detailed description

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir AR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir AR LP or a single-chamber atrial transvenous pacemaker system from any manufacturer.

Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Interventions

  • Device Aveir AR Leadless Pacemaker
    This study will utilize real-world data from patients implanted with the Aveir AR Leadless Pacemaker. No device intervention is required in this study.
  • Device Single-chamber atrial transvenous pacemaker
    This study will utilize real-world data from patients implanted with a single-chamber atrial transvenous pacemaker as a comparator to the Aveir AR LP study arm. No device intervention is required in this study

Primary outcome measures

  • Acute device-related complication rate [Time frame: 30 days]
  • Two-year survival rate [Time frame: 2 years]
Secondary outcome measures (2)
  • Chronic complication rate [Time frame: 6 months]
  • Device related re-intervention rate [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study.

OR

  • Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial 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: NCT06100770 · ABT-CIP-CL1021378

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗