Amplatzer Amulet LAAO vs. NOAC
Public ClinicalTrials.gov record NCT04226547. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04226547
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 2,650 participants
Conditions and interventions
Conditions
Interventions
- Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) Device
- Non-Vitamin K Oral Antagonists Drug
Device · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2020 (Actual)
- Primary completion
- Jan 2029 (Estimated)
- Completion
- Apr 2031 (Estimated)
- Last update posted
- Feb 10, 2026
2020 – 2031
United States locations
- U.S. sites
- 79
- U.S. states
- 33
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Hospital - Univ. of Alabama at Birmingham (UAB) | Birmingham | Alabama | 35249 | — |
| Heart Center Research, LLC | Huntsville | Alabama | 35801 | — |
| Arizona Cardiovascular Research Center | Phoenix | Arizona | 85016 | — |
| Tucson Medical Center | Tucson | Arizona | 85712 | — |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | — |
| UAMS Medical Center | Little Rock | Arkansas | 72205 | — |
| Scripps Health | La Jolla | California | 92037 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Huntington Memorial Hospital | Pasadena | California | 91109 | — |
| Mercy Medical Group - Cardiology | Sacramento | California | 95819 | — |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| AdventHealth Florida Cardiology - Altamonte Springs | Altamonte Springs | Florida | 32701 | — |
| St. Vincent's Medical Center | Jacksonville | Florida | 32204 | — |
| Baptist Medical Center | Jacksonville | Florida | 32207 | — |
| AdventHealth Florida Cardiology - Lake Mary | Lake Mary | Florida | 32746 | — |
| NCH Healthcare System | Naples | Florida | 34102 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| AdventHealth Florida Cardiology - Oviedo | Oviedo | Florida | 32765 | — |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | — |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| St. Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Northside Hospital (CardioVascular Group Lawrenceville) | Lawrenceville | Georgia | 30045 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| Central DuPage Hospital | Winfield | Illinois | 60190 | — |
| Lutheran Hospital of Indiana | Fort Wayne | Indiana | 46801 | — |
| St. Vincent Hospital | Indianapolis | Indiana | 46240 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | — |
| Overland Park Mid America Cardiology | Overland Park | Kansas | 66211 | — |
| Via Christi Regional Medical Center - St. Francis Campus | Wichita | Kansas | 67214 | — |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | — |
| Our Lady of the Lake Physician Group | Baton Rouge | Louisiana | 70808 | — |
| Cardiovascular Institute of the South | Houma | Louisiana | 70361 | — |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Spectrum Health Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| VA Medical Center Minneapolis | Minneapolis | Minnesota | 55417 | — |
| St. Cloud Hospital - Central MN Heart Clinic | Saint Cloud | Minnesota | 56303 | — |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | — |
| Bryan Heart | Lincoln | Nebraska | 68506 | — |
| CHI Health Creighton University Medical Center-Bergan Mercy | Omaha | Nebraska | 68124 | — |
| Cooper University Hospital | Camden | New Jersey | 08103 | — |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | — |
| South Shore University Hospital-Northwell | Bay Shore | New York | 11706 | — |
| Buffalo General Hospital | Buffalo | New York | 14203 | — |
| Mount Sinai Hospital | New York | New York | 10019 | — |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10021 | — |
| Staten Island University Hospital Northwell | Staten Island | New York | 10305 | — |
| Mission Health & Hospitals | Asheville | North Carolina | 28801 | — |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | — |
| TriHealth Bethesda North Hospital | Cincinnati | Ohio | 45242 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | — |
| Oklahoma Heart Institute at Utica | Tulsa | Oklahoma | 74104 | — |
| Pinnacle Health System | Harrisburg | Pennsylvania | 17105 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| WellSpan Health | York | Pennsylvania | 17403 | — |
| Roper Hospital | Charleston | South Carolina | 29401 | — |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57117 | — |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | — |
| Tennova Healthcare-Turkey Creek Medical Center | Knoxville | Tennessee | 37920 | — |
| Vanderbilt Heart & Vascular Institute | Nashville | Tennessee | 37232 | — |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | — |
| Baylor All Saints Medical Center at Fort Worth | Forth Worth | Texas | 76104 | — |
| Park Plaza Hospital | Houston | Texas | 77004 | — |
| CHI St. Luke's Health Baylor College of Medicine Med. Ctr. | Houston | Texas | 77030 | — |
| Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| The Methodist Hospital | Houston | Texas | 77030 | — |
| Memorial Katy Cardiology Associates | Houston | Texas | 77094 | — |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | — |
| Methodist Texsan Hospital | San Antonio | Texas | 78201 | — |
| Heart Rhythm Associates | Shenandoah | Texas | 77380 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Monongalia General Hospital | Morgantown | West Virginia | 26505 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04226547, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 10, 2026 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04226547 live on ClinicalTrials.gov.