Recruiting NCT06100770

Aveir AR Coverage With Evidence Development (CED) Study

Trial Parameters

Condition Cardiac Pacemaker

Sponsor Abbott Medical Devices

Study Type OBSERVATIONAL

Phase N/A

Enrollment 586

Sex ALL

Min Age 18 Years

Max Age N/A

Start Date 2024-01-18

Completion 2030-01

All Conditions

Cardiac Pacemaker Arrhythmia Bradycardia

Interventions

Aveir AR Leadless PacemakerSingle-chamber atrial transvenous pacemaker

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

Eligibility Criteria

Inclusion Criteria: 1. 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 2. 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

Related Trials

NCT06100770

Aveir AR Coverage With Evidence Development (CED) Study

View Trial →

NCT05336877

Aveir VR Coverage With Evidence Development Post-Approval Study

View Trial →

VIEW ON CLINICALTRIALS.GOV ↗ MORE CARDIAC PACEMAKER TRIALS