🏛️ Verified NIH Record • Updated 2026-01-28

Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation (NCT05462145)

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Kardium Inc.

🩺 Plain-English Summary (8th-Grade Level)

This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).

Who can join: Review the eligibility criteria below.

Location: Grandview Medical Center — Birmingham, Alabama

Age range: 18 Years to 80 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (18 Sites)

  • Grandview Medical Center — Birmingham, Alabama
  • St. Bernards Medical Center — Jonesboro, Arkansas
  • Sutter Health - California Pacific Medical Center — San Francisco, California
  • St. Vincent's Medical Center — Jacksonville, Florida
  • Mercy Hospital — Miami, Florida
  • Johns Hopkins — Baltimore, Maryland
  • Beaumont Hospital — Royal Oak, Michigan
  • Mt. Sinai Hospital, Guggenheim Pavilion — New York, New York
  • Cleveland Clinic — Cleveland, Ohio
  • Doylestown Hospital — Doylestown, Pennsylvania
  • Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
  • Texas Cardiac Arrhythmia Research Foundation — Austin, Texas
  • St.Paul's Hospital — Vancouver, British Columbia
  • McGill University Health Centre — Montreal, Quebec
  • Motol and Homolka University Hospital — Prague,
  • Heart and Diabetes Center NRW — Bad Oeynhausen,
  • Charité Campus Virchow Clinic — Berlin,
  • Westpfalz-Klinikum GmbH Kaiserslautern — Kaiserslautern,

💰 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗