Clinical trial NCT03039712: Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Official title: Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bradycardia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2017-02-01
Enrollment: 37000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute complication rate
timeFrame: 30 days
measure: The 2-year survival rate of patients implanted with a Micra leadless pacemaker
timeFrame: 2 years
Secondary outcomes:
measure: Chronic complication rate
timeFrame: 6 months
measure: Device-related re-intervention rates
timeFrame: 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Mikhael El Chami, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.