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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235491
Recruitment Status : Active, not recruiting
First Posted : January 22, 2020
Last Update Posted : February 28, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic

Study Description
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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 Micra AV leadless pacemakers or dual-chamber transvenous pacemakers.

Condition or disease
Bradycardia

Detailed Description:

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.

Study Design
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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 AV Leadless Pacemakers
Actual Study Start Date : February 6, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024
Groups and Cohorts
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Group/Cohort
Micra AV leadless pacemaker therapy
All Medicare patients implanted with a Micra AV leadless pacemaker system
Dual Chamber Transvenous pacemaker
All Medicare patients implanted with full system (e.g. lead and generator) dual-chamber transvenous pacemakers


Outcome Measures
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Primary Outcome Measures :
  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 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 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.


Eligibility Criteria
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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 AV leadless pacemaker or a full-system dual-chamber transvenous pacemaker in any US location.
Criteria

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
Contacts and Locations
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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): NCT04235491


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
More Information
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Responsible Party: Medtronic
ClinicalTrials.gov Identifier: NCT04235491    
Other Study ID Numbers: Micra AV CED Study
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: February 28, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes