Heart device vs. pills: which better prevents strokes in AFib patients?

NCT ID NCT04226547

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests if a device that closes a small pouch in the heart (left atrial appendage) is safer and more effective than long-term blood thinners for preventing strokes in people with atrial fibrillation. About 2,650 participants with AFib and high stroke risk are randomly assigned to get either the device or a standard blood thinner. The goal is to see which approach better reduces strokes, bleeding, and heart-related deaths.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,650 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder) * At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women * Eligible for long-term NOAC therapy * Able to comply with the required NOAC medication regimen if randomized to the Control Group * Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in * Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment * 18 years of age or older, or the age of legal consent * Able and willing to return for required follow-up visits and assessments Exclusion Criteria: * Requires long-term OAC therapy for a condition other than AF * Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable) * Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use * Indicated for P2Y12 platelet inhibitor for \>1 year post-randomization * In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure * Has undergone atrial septal defect (ASD) repair or has an ASD closure device present * Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted * Is implanted with a mechanical valve prosthesis * Is implanted with an inferior vena cava filter * History of rheumatic or congenital mitral valve heart disease * Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has active infection or bleeding disorder) * Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer) * Experienced stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable) * Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization * Underwent catheter ablation for AF or atrial flutter within 60 days prior to randomization * Experienced myocardial infarction within 90 days prior to randomization * New York Heart Association Class IV Congestive Heart Failure * Left ventricular ejection fraction ≤ 30% (per most recent assessment) * Symptomatic carotid disease (defined as \> 50% lumen diameter narrowing on CTA, MRA, or TCD with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \< 50% lumen diameter narrowing * Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale) * Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) * History of idiopathic or recurrent venous thromboembolism * LAA is obliterated or surgically ligated * Thrombocytopenia (defined as \< 50,000 platelets per microliter (\<50 x 10\^9 /L)or anemia (defined as hemoglobin \< 10 g/dL) requiring transfusions * Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy) * Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial * Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation * Active endocarditis or other infection producing bacteremia * Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.) * Severe renal failure (estimated glomerular filtration rate \<30 ml/min/1.73m2), but not on dialysis * Life expectancy is less than 2 years in the opinion of the Investigator * Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage hemorrhagic disease stroke disorder ischemic stroke prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation Bleeding Stroke

Contacts and locations

Locations

AdventHealth Florida Cardiology - Altamonte Springs

Altamonte Springs, Florida, 32701, United States
AdventHealth Florida Cardiology - Lake Mary

Lake Mary, Florida, 32746, United States
AdventHealth Florida Cardiology - Oviedo

Oviedo, Florida, 32765, United States
AdventHealth Orlando

Orlando, Florida, 32803, United States
Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States
Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States
Baptist Health Lexington

Lexington, Kentucky, 40503, United States
Baptist Medical Center

Jacksonville, Florida, 32207, United States
Baylor All Saints Medical Center at Fort Worth

Forth Worth, Texas, 76104, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Bryan Heart

Lincoln, Nebraska, 68506, United States
Buffalo General Hospital

Buffalo, New York, 14203, United States
CHI Health Creighton University Medical Center-Bergan Mercy

Omaha, Nebraska, 68124, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

Houston, Texas, 77030, United States
CHU Gabriel Montpied

Clermont-Ferrand, 63003, France
CHUM

Montreal, H2X 3E4, Canada
Cardioangiologisches Centrum am Bethanien Krankenhaus

Frankfurt, 60389, Germany
Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States
Center Inselspital Bern

Bern, 3010, Switzerland
Central DuPage Hospital

Winfield, Illinois, 60190, United States
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

Lodz, 92-213, Poland
Chiba University

Chiba, Chiba, 260-8677, Japan
Cooper University Hospital

Camden, New Jersey, 08103, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States
Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia
Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia
Fondazione Toscana Gabriele Monasterio

Massa, 54100, Italy
Heart Center Research, LLC

Huntsville, Alabama, 35801, United States
Heart Rhythm Associates

Shenandoah, Texas, 77380, United States
Helios Klinikum Siegburg

Siegburg, 53721, Germany
Hightower Clinical

Oklahoma City, Oklahoma, 73102, United States
Hopital Haut Leveque

Pessac, 33604, France
Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain
Hospital Clinico San Carlos

Madrid, Madrid, Spain
Hospital Universitario de Salamanca

Salamanca, 37007, Spain
Hospital de la Santa Creu I Sant Pau

Barcelona, 08025, Spain
Huntington Memorial Hospital

Pasadena, California, 91109, United States
Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, H1T 1C8, Canada
Institute Cardio. Paris-Sud - Institut Jacques Cartier

Massy, 91300, France
Institute of Science Tokyo Hospital

Tokyo, Tokyo, 113-8519, Japan
Internistisches Klinikum München SUD

Munich, 81379, Germany
Jackson Heart Clinic

Jackson, Mississippi, 39216, United States
Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States
Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
Klinikum der Justus-Liebig-Universität

Giessen, 35392, Germany
Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan
Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, Japan
Lutheran Hospital of Indiana

Fort Wayne, Indiana, 46801, United States
MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Memorial Hermann Hospital

Houston, Texas, 77030, United States
Memorial Katy Cardiology Associates

Houston, Texas, 77094, United States
Mercy Medical Group - Cardiology

Sacramento, California, 95819, United States
Methodist Texsan Hospital

San Antonio, Texas, 78201, United States
Mission Health & Hospitals

Asheville, North Carolina, 28801, United States
Monongalia General Hospital

Morgantown, West Virginia, 26505, United States
Mount Sinai Hospital

New York, New York, 10019, United States
Mutualiste Montsouris

Paris, 75014, France
NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States
NCH Healthcare System

Naples, Florida, 34102, United States
Nemocnice Na Homolce

Prague, 150 30, Czechia
New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States
New York Presbyterian Hospital/Cornell University

New York, New York, 10021, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
Northside Hospital (CardioVascular Group Lawrenceville)

Lawrenceville, Georgia, 30045, United States
Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States
Oklahoma Heart Institute at Utica

Tulsa, Oklahoma, 74104, United States
Ospedale San Raffaele

Milan, 20132, Italy
Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada
Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, 70808, United States
Overland Park Mid America Cardiology

Overland Park, Kansas, 66211, United States
Park Plaza Hospital

Houston, Texas, 77004, United States
Piedmont Heart Institute

Atlanta, Georgia, 30309, United States
Pinnacle Health System

Harrisburg, Pennsylvania, 17105, United States
Prince of Wales Hospital

Hong Kong, 999077, Hong Kong
Queen Elizabeth Hospital

Hong Kong, Hong Kong
Rigshospitalet

Copenhagen, 2100, Denmark
Roper Hospital

Charleston, South Carolina, 29401, United States
Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia
Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States
Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States
Scripps Health

La Jolla, California, 92037, United States
Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany
Sendai Kousei Hospital

Sendai, Miyagi, 980-0973, Japan
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Shonan Kamakura General Hospital

Kamakura, Kanagawa, 247-8533, Japan
Skejby University Hospital

Aarhus, 8200, Denmark
Slaskie Centrum Chorob Serca

Zabrze, 41-800, Poland
South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States
South Shore University Hospital-Northwell

Bay Shore, New York, 11706, United States
Spectrum Health Butterworth Hospital

Grand Rapids, Michigan, 49503, United States
St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands
St. Cloud Hospital - Central MN Heart Clinic

Saint Cloud, Minnesota, 56303, United States
St. Joseph's Hospital

Atlanta, Georgia, 30342, United States
St. Marien-Hospital-Bonn

Bonn, 53115, Germany
St. Vincent Hospital

Indianapolis, Indiana, 46240, United States
St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States
Stadtspital Triemli

Zurich, 8063, Switzerland
Staten Island University Hospital Northwell

Staten Island, New York, 10305, United States
Tennova Healthcare-Turkey Creek Medical Center

Knoxville, Tennessee, 37920, United States
Texas Cardiac Arrhythmia

Austin, Texas, 78705, United States
The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States
The Methodist Hospital

Houston, Texas, 77030, United States
The Royal Sussex County Hospital

Brighton, BN25BE, United Kingdom
The University of Hong Kong (Queen Mary Hospital)

Hong Kong, Hong Kong
Toho University Ohashi Medical Center

Meguro-ku, Tokyo, 153-8515, Japan
Toyohashi Heart Center

Toyohashi, Aichi-ken, 441-8530, Japan
TriHealth Bethesda North Hospital

Cincinnati, Ohio, 45242, United States
Tucson Medical Center

Tucson, Arizona, 85712, United States
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UAMS Medical Center

Little Rock, Arkansas, 72205, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35249, United States
University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States
University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan
Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

Berlin, Brandenburg, 12203, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany
VA Medical Center Minneapolis

Minneapolis, Minnesota, 55417, United States
Vancouver General Hospital (U of BC)

Vancouver, V5Z 1M9, Canada
Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232, United States
Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214, United States
Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08661, Lithuania
WellSpan Health

York, Pennsylvania, 17403, United States

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