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

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ClinicalTrials.gov Identifier: NCT03039712
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic

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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 37000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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



Primary Outcome Measures :
  1. Acute complication rate [ Time Frame: 30 days ]
    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.

  2. The 2-year survival rate of patients implanted with a Micra leadless pacemaker [ Time Frame: 2 years ]
    Estimate the 2-year survival rate of patients implanted with a Micra leadless pacemaker


Secondary Outcome Measures :
  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 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.

  2. Device-related re-intervention rates [ Time Frame: 2 years ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

• Medicare beneficiaries implanted with a leadless pacemaker (CPT 0387T 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039712


Locations
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United States, Georgia
Emory University
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Medtronic
Investigators
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Principal Investigator: Mikhael El Chami, MD Emory University
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT03039712    
Other Study ID Numbers: Micra CED Study
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes