Active — Not RecruitingNot Applicable

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

United States37,000 participantsStarted 2020-02-06

Plain-language 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. Patients are enrolled through submission of claims or encounter data to CMS.

Who can participate

SexALL

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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

What they're measuring

Acute complication rate

Timeframe: 30 days

The 2-year survival of patients implanted with a Micra AV leadless pacemaker

Timeframe: 2 years

Trial details

NCT IDNCT04235491

SponsorMedtronic

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-06

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