🏛️ Verified NIH Record • Updated 2025-09-26

Amulet™ ADVANCE LAA (NCT05997446)

A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Abbott Medical Devices

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

This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.

Who can join: Review the eligibility criteria below.

Location: Arizona Arrhythmia Research — Phoenix, Arizona

Age range: 18 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 (16 Sites)

  • Arizona Arrhythmia Research — Phoenix, Arizona
  • Arkansas Heart Hospital — Little Rock, Arkansas
  • Baptist Medical Center — Jacksonville, Florida
  • Usman R. Siddiqui, MD — Winter Park, Florida
  • PERC - O'Fallon — O'Fallon, Illinois
  • Kansas City Cardiac Arrhythmia Research Foundation — Overland Park, Kansas
  • Cardiovascular Research Institute of Kansas — Wichita, Kansas
  • Providence Hospital — Southfield, Michigan
  • Bryan Heart — Lincoln, Nebraska
  • CHI Health Creighton University Medical Center-Bergan Mercy — Omaha, Nebraska
  • New York University Hospital — New York, New York
  • Pinnacle Health System — Mechanicsburg, Pennsylvania
  • Trident Medical Center — Charleston, South Carolina
  • Vanderbilt Heart & Vascular Institute — Nashville, Tennessee
  • Baylor All Saints Medical Center at Fort Worth — Fort Worth, Texas
  • Heart Rhythm Associates — Shenandoah, Texas

💰 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 ↗