Amplatzer Amulet LAAO vs. NOAC (NCT04226547)
Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants
🩺 Plain-English Summary (8th-Grade Level)
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.
Who can join: Review the eligibility criteria below.
Location: University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "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 (127 Sites)
Showing the first 25 of 127 sites.
- University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama
- Heart Center Research, LLC — Huntsville, Alabama
- Arizona Cardiovascular Research Center — Phoenix, Arizona
- Tucson Medical Center — Tucson, Arizona
- Arrhythmia Research Group — Jonesboro, Arkansas
- UAMS Medical Center — Little Rock, Arkansas
- Scripps Health — La Jolla, California
- Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
- Huntington Memorial Hospital — Pasadena, California
- Mercy Medical Group - Cardiology — Sacramento, California
- South Denver Cardiology Associates PC — Littleton, Colorado
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- AdventHealth Florida Cardiology - Altamonte Springs — Altamonte Springs, Florida
- St. Vincent's Medical Center — Jacksonville, Florida
- Baptist Medical Center — Jacksonville, Florida
- AdventHealth Florida Cardiology - Lake Mary — Lake Mary, Florida
- NCH Healthcare System — Naples, Florida
- AdventHealth Orlando — Orlando, Florida
- AdventHealth Florida Cardiology - Oviedo — Oviedo, Florida
- Sarasota Memorial Hospital — Sarasota, Florida
- Piedmont Heart Institute — Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia
- Northside Hospital — Atlanta, Georgia
- St. Joseph's Hospital — Atlanta, Georgia
- Northside Hospital (CardioVascular Group Lawrenceville) — Lawrenceville, 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.
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💡 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.