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Active, Not Recruiting

NCT Number: NCT04235491

Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED)

The primary purpose of the study is to meet the CMS mandated Coverage with Evidence Development requirement in the National Coverage Determination for Leadless Pacemakers as they apply to Medtronic Micra devices. The study uses administrative claims data of the Medicare population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University

Atlanta, Georgia, 30308, United States

About this study

The Micra AV CED study is a study of the Medicare beneficiary population implanted with Micra AV leadless pacemakers or dual-chamber transvenous pacemakers and will be executed by analyzing administrative claims data. The study consists of two primary objectives: estimate the (1) acute overall complication rate, and (2) the 2-year survival rate of patients implanted with a Micra AV leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra AV leadless pacemakers to dual-chamber transvenous pacemakers will be conducted.

The analysis will be in CMS claims data and is subject to a central IRB. However, individual hospitals are not engaged in research and local IRB oversight is not necessary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medicare beneficiaries implanted with a Micra AV leadless pacemaker (CPT 0387T or 33274 or ICD-10 PCS 02HK3NZ) on or after the study start date will be included in the study.

or

  • Medicare beneficiaries implanted with a dual-chamber ventricular transvenous pacemaker [CPT 33208 or 33213 or 33214 or ICD-10 PCS ((0JH606Z or 0JH636Z) + (02H60JZ or 02H63JZ or 02H70JZ or 02H73JZ) + (02HK0JZ or 02HK3JZ))] on or after the study start date.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Acute complication rate

    Time frame: 30 days

    Micra AV leadless pacemaker system and/or procedure related complications at 30 days. Acute complications include embolism/thrombosis, event at the puncture site, cardiac effusion/perforation, device-related complication, or other complications following the implantation of a Micra AV leadless pacemaker system. Subjects' administrative claims data will be reviewed to determine the occurrence of an acute complication.

  2. The 2-year survival of patients implanted with a Micra AV leadless pacemaker

    Time frame: 2 years

    Estimate the 2-year survival rate of patients implanted with a Micra AV leadless pacemaker

Secondary outcomes

  1. Chronic complication rate

    Time frame: 6 months

    Chronic complications are a subset of acute complications that may also occur within six months following the implantation of a Micra AV leadless pacemaker. Micra AV leadless pacemaker system and/or procedure related complications at six months. Subjects' administrative claims data will be reviewed to determine the occurrence of a chronic complication.

  2. Device-related re-intervention rates

    Time frame: 2 years

    Device-related re-interventions are procedures associated with the insertion/replacement, revision, or removal or either a leadless or transvenous pacemaker system or components following the index implantation of a Micra AV leadless pacemaker. Device-related re-intervention rates will be reported at six month intervals for two years following the index implantation of a single-chamber ventricular pacemaker. Subjects' administrative claims data will be reviewed to determine the occurrence of a device-related re-intervention.

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Official study title

Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers

Important dates

Study start
2020
Primary completion
2029
Study completion
2029
First posted
Jan 22, 2020
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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