Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (Micra 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 single-chamber ventricular pacemakers. Patients are enrolled through submission of claims or encounter data to CMS.

Study Overview

• Status: Active, not recruiting
• Conditions: Bradycardia

Detailed Description

Micra CED study is a study of the Medicare beneficiary population implanted with single-chamber ventricular 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 leadless pacemaker. As part of the secondary objectives of the study, a comparative analysis of Micra leadless pacemakers to single-chamber ventricular 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.

• Study Type: Observational
• Enrollment (Estimated): 37000

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study cohort will include all Medicare patients with continuous claims data implanted with a Micra leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker in any US location.

Description

Inclusion Criteria:

• Medicare beneficiaries implanted with a 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 with implanted with a full system single-chamber ventricular transvenous pacemaker (CPT 33207 or ICD-10 PCS 0JH605Z or 0JH604Z and 02HK3JZ) on or after the study start date.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Micra leadless pacemaker therapy; All Medicare patients implanted with Micra leadless pacemaker system
Single Chamber Transvenous pacemaker; All Medicare patients implanted with full system (e.g. lead and generator) single- chamber ventricular transvenous pacemakers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute complication rate	Single-chamber ventricular 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 single-chamber ventricular pacemaker system. Subjects' administrative claims data will be reviewed to determine the occurrence of an acute complication.	30 days
The 2-year survival rate of patients implanted with a Micra leadless pacemaker	Estimate the 2-year survival rate of patients implanted with a Micra leadless pacemaker	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic complication rate	Chronic complications are a subset of acute complications that may also occur within six months following the implantation of a single-chamber ventricular pacemaker. Single-chamber ventricular 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.	6 months
Device-related re-intervention rates	Device-related re-interventions are procedures associated with the insertion/replacement, revision, or removal of either a leadless or transvenous pacemaker system or components following the index implantation of a single-chamber ventricular 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	2 years

Collaborators and Investigators

• Sponsor: Medtronic
• Investigators: Principal Investigator: Mikhael El Chami, MD, Emory University

Publications and helpful links

General Publications

• El-Chami MF, Bockstedt L, Longacre C, Higuera L, Stromberg K, Crossley G, Kowal RC, Piccini JP. Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. Eur Heart J. 2022 Mar 21;43(12):1207-1215. doi: 10.1093/eurheartj/ehab767.
• Crossley GH, Piccini JP, Longacre C, Higuera L, Stromberg K, El-Chami MF. Leadless versus transvenous single-chamber ventricular pacemakers: 3 year follow-up of the Micra CED study. J Cardiovasc Electrophysiol. 2023 Apr;34(4):1015-1023. doi: 10.1111/jce.15863. Epub 2023 Feb 23.
• Boveda S, Higuera L, Longacre C, Wolff C, Wherry K, Stromberg K, El-Chami MF. Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups. Europace. 2023 Mar 30;25(3):1041-1050. doi: 10.1093/europace/euad016.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimated): February 1, 2017

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Bradycardia
• Other Study ID Numbers: Micra CED Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No