🏛️ Verified NIH Record • Updated 2025-09-23
Longitudinal Coverage With Evidence Development Study on Micra Leadless Pacemakers (NCT03039712)
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Medtronic
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Emory University — Atlanta, Georgia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Emory University — Atlanta, Georgia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bradycardia
- Micra Transcatheter Pacing System Post-Approval Registry — Birmingham, Alabama
- Longitudinal Coverage With Evidence Development Study on Micra AV Leadless Pacemakers (Micra AV CED) — Atlanta, Georgia
- Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED) — Avondale, Arizona
- The Alaska Oculocardiac Reflex Study — Anchorage, Alaska
- His Bundle Pacing in Bradycardia and Heart Failure — Rochester, Minnesota
Explore by condition: All Bradycardia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.