NCT03039712

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37,000

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Mar 2017Jun 2029

First Submitted

Initial submission to the registry

January 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2017

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

12.2 years

First QC Date

January 27, 2017

Last Update Submit

September 23, 2025

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Chronic complication rate

    6 months

  • Device-related re-intervention rates

    2 years

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30308, United States

Location

Related Publications (3)

  • 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.

    PMID: 36807378DERIVED

  • 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.

    PMID: 36757859DERIVED

  • 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.

    PMID: 34788416DERIVED

MeSH Terms

Conditions

Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mikhael El Chami, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 1, 2017

Study Start

March 10, 2017

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)