Clinical Trial: Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers

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

Detailed Summary: 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.
Sponsor: Medtronic

Current Primary Outcome:

  • 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.
  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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


Original Secondary Outcome: Same as current

Information By: Medtronic

Dates:
Date Received: January 27, 2017
Date Started: March 10, 2017
Date Completion: June 2021
Last Updated: March 10, 2017
Last Verified: March 2017