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

Medtronic

Status: Active, not recruiting

Conditions: Bradycardia

Study type: Observational

Funder types: Industry

Identifiers

NCT04235491

Micra AV CED Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

37,000 participants in 2 patient groups

Micra AV leadless pacemaker therapy

Description:

All Medicare patients implanted with a Micra AV leadless pacemaker system

Dual Chamber Transvenous pacemaker

Description:

All Medicare patients implanted with full system (e.g. lead and generator) dual-chamber transvenous pacemakers