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Clinical Trials in the USA / NCT03039712
Active, not recruiting Observational

Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers

NCT03039712 · tracked via the Priya Life Science USA tracker
Sponsor
Medtronic
Phase
Observational
Started
2017-03-10
Last updated
2026-10-09

Condition(s) studied

Bradycardia

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Acute complication rate — 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 — 2 years
    Estimate the 2-year survival rate of patients implanted with a Micra leadless pacemaker

Trial sites (1)

FacilityCityRegionStatus
Emory University Atlanta Georgia

More Medtronic trials in the USA

Lead Evaluation for Defibrillation and Reliability Post Approval Study Enrolling by invitation
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy Recruiting
Enlighten Study: The EV-ICD Post Approval Registry Active, not recruiting
Product Surveillance Registry Recruiting
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED) Active, not recruiting

Other trials for the same condition

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System Recruiting
Aveir DR Real-World Evidence Post-Approval Study Recruiting
Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED) Active, not recruiting
Chronic Evaluation of Novel Pacemaker System Recruiting
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03039712 on ClinicalTrials.gov ↗ ← All trials in the USA