Study Results
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View full resultsBasic Information
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COMPLETED
NA
1878 participants
INTERVENTIONAL
2016-08-24
2024-05-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Amulet
Amulet left atrial appendage occluder
Amulet Left Atrial Appendage Occluder
Transcatheter left atrial appendage closure
WATCHMAN (Control)
WATCHMAN left atrial appendage closure device
WATCHMAN Left Atrial Appendage Closure
Transcatheter left atrial appendage closure
Interventions
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Amulet Left Atrial Appendage Occluder
Transcatheter left atrial appendage closure
WATCHMAN Left Atrial Appendage Closure
Transcatheter left atrial appendage closure
Eligibility Criteria
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Inclusion Criteria
2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
3. At high risk of stroke or systemic embolism defined as CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3
4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record)
7. Able to comply with the required medication regimen post-device implant
8. Able to understand and willing to provide written informed consent to participate in the trial
9. Able and willing to return for required follow-up visits and examinations
Exclusion Criteria
2. Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
3. Indicated for chronic P2Y12 platelet therapy inhibitor
4. Is considered at high risk for general anesthesia, in the opinion of the investigator, and/or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay (criterion is only applicable where general anesthesia is planned for the study procedure).
5. Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
6. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
7. Implanted with a mechanical valve prosthesis
8. Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
9. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
10. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure (e.g. cardioversion, ablation, cataract surgery, etc.)
11. Myocardial infarction (MI) within 90 days prior to randomization
12. New York Heart Association Class IV Congestive Heart Failure
13. Left ventricular ejection Fraction (LVEF) ≤30%
14. Symptomatic carotid artery disease (defined as \>50% stenosis 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% stenosis
15. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
16. History of idiopathic or recurrent venous thromboembolism
17. Left atrial appendage is obliterated or surgically ligated
18. Thrombocytopenia or anemia requiring transfusions
19. Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)
20. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
21. Subject is pregnant or pregnancy is planned during the course of the investigation
22. Active endocarditis or other infection producing bacteremia
23. Subject has had a transient case of AF (i.e. never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
24. Subjects with severe renal failure (estimated glomerular filtration rate \<30ml/min/1.73m²)
25. Subject whose life expectancy is less than 2 years
26. 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 trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results.
1. Intracardiac thrombus visualized by echocardiographic imaging
2. Existing circumferential pericardial effusion \>2mm
3. Significant mitral valve stenosis (i.e. mitral valve area \<1.5 cm\^2)
4. High risk PFO, defined as an atrial septal aneurysm (excursion \> 15mm or length ≥ 15mm; excursion defined as maximal protrusion of the atrial septal aneurysm \[ASA\] beyond the plane of the atrial septum) or large shunt (early, within 3 beats and/or substantial passage of bubbles i.e. ≥ 20)
5. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
6. Cardiac tumor
7. LAA anatomy cannot accommodate either a Boston Scientific LAA closure device or Amulet device, as per manufacturer's Instructions for Use (IFU). (i.e. the LAA anatomy and sizing must be appropriate for both devices in order to be enrolled in the trial. This is applicable to all roll-in and randomized subjects).
8. Placement of the device would interfere with any intracardiac or intravascular structure
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy, MD
Role: STUDY_CHAIR
University of Kansas
David Thaler, MD, PhD
Role: STUDY_CHAIR
The Comprehensive Stroke Center at Tufts Medical Center
Stephan Windecker, MD, PhD
Role: STUDY_CHAIR
Inselspital, University of Bern
Locations
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Heart Center Research, LLC.
Huntsville, Alabama, United States
Banner-University Medical Center Phoenix
Phoenix, Arizona, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
St. Bernards Medical Center
Jonesboro, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Scripps Health
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
USC University Hospital
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
Mercy Medical Group - Cardiology
Sacramento, California, United States
San Diego Cardiac Center
San Diego, California, United States
Pacific Heart Institute
Santa Monica, California, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Bradenton Cardiology Center
Bradenton, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Watson Clinic Center
Lakeland, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Midwest Cardiovascular Institute
Naperville, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Kansas City Cardiac Arrhythmia Research Foundation
Overland Park, Kansas, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Charlton Memorial Hospital
Fall River, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Beaumont Hospital, Royal Oak
Royal Oak, Michigan, United States
VA Medical Center Minneapolis
Minneapolis, Minnesota, United States
St. Cloud Hospital (Central MN Heart Clinic)
Saint Cloud, Minnesota, United States
St. Joseph's Hospital
Saint Paul, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Albany Medical Center
Albany, New York, United States
Winthrop-University Hospital
Mineola, New York, United States
New York University Hospital
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian/Columbia University Medical Center
New York, New York, United States
Mission Health & Hospitals
Asheville, North Carolina, United States
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma Heart Institute at Utica
Tulsa, Oklahoma, United States
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
Roper Hospital
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Vanderbilt Heart Institute
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
Austin Heart
Austin, Texas, United States
The Methodist Hospital
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
University of Vermont College of Medicine
Burlington, Vermont, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Specialist Cardiology
Wahroonga, New South Wales, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
St. Andrew's Hospital
Adelaide, South Australia, Australia
HeartCare St John of God Wexford Medical Centre
Murdoch, Western Australia, Australia
Vancouver General Hospital (U of BC)
Vancouver, British Columbia, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
Nemocnice Na Homolce
Prague, Central Bohemia, Czechia
Skejby University Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Kliniken Villingen-Schwenningen
Villingen-Schwenningen, Bad-wur, Germany
Klinikum Coburg GmbH
Coburg, Bavaria, Germany
Internistisches Klinikum München SUD
Munich, Bavaria, Germany
Cardioangiologisches Centrum am Bethanien Krankenhaus
Frankfurt am Main, Hesse, Germany
CardioVaskuläres Centrum St. Katharinen
Frankfurt am Main, Hesse, Germany
Evangelisches Krankenhaus Bielefeld
Bielefeld, North Rhine, Germany
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, North Rhine, Germany
Elisabeth-Krankenhaus Essen GmbH
Essen, North Rhin, Germany
UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland, Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany
Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Ospedale San Raffaele - Aritmologia
Milan, Lombard, Italy
St. Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
Santa Maria Hospital
Lisbon, Lisbon District, Portugal
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital General Juan Ramon Jimenez
Huelva, Andalu, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Catalonia, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, Spain
Center Inselspital Bern
Bern, , Switzerland
Countries
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References
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Nielsen-Kudsk JE, Schmidt B, Windecker S, Shah N, Gray W, Ellis CR, Koulogiannis K, Anderson JA, Gage R, Lakkireddy D. Characterization and Clinical Outcomes of High-Risk Device-Related Thrombus in the Amulet IDE Trial. JACC Clin Electrophysiol. 2025 Jul;11(7):1543-1554. doi: 10.1016/j.jacep.2025.02.016. Epub 2025 Apr 9.
Lakkireddy D, Ellis CR, Thaler D, Swarup V, Gambhir A, Hermiller J, Nielsen-Kudsk JE, Worthley S, Nair D, Schmidt B, Horton R, Gupta N, Anderson JA, Zhao H, Alkhouli M, Windecker S. 5-Year Results From the AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled Trial. J Am Coll Cardiol. 2025 Mar 25;85(11):1141-1153. doi: 10.1016/j.jacc.2024.10.101. Epub 2024 Nov 18.
Lakkireddy D, Thaler D, Ellis CR, Swarup V, Gambhir A, Hermiller J, Nielsen-Kudsk JE, Worthley S, Nair D, Schmidt B, Horton R, Gupta N, Anderson JA, Gage R, Alkhouli M, Windecker S. 3-Year Outcomes From the Amplatzer Amulet Left Atrial Appendage Occluder Randomized Controlled Trial (Amulet IDE). JACC Cardiovasc Interv. 2023 Aug 14;16(15):1902-1913. doi: 10.1016/j.jcin.2023.06.022.
Lakkireddy D, Nielsen-Kudsk JE, Windecker S, Thaler D, Price MJ, Gambhir A, Gupta N, Koulogiannis K, Marcoff L, Mediratta A, Anderson JA, Gage R, Ellis CR. Mechanisms, predictors, and evolution of severe peri-device leaks with two different left atrial appendage occluders. Europace. 2023 Aug 2;25(9):euad237. doi: 10.1093/europace/euad237.
Schmidt B, Nielsen-Kudsk JE, Ellis CR, Thaler D, Sabir SA, Gambhir A, Landmesser U, Shah N, Gray W, Swarup V, Lim DS, Koulogiannis K, Anderson JA, Gage R, Lakkireddy D. Incidence, Predictors, and Clinical Outcomes of Device-Related Thrombus in the Amulet IDE Trial. JACC Clin Electrophysiol. 2023 Jan;9(1):96-107. doi: 10.1016/j.jacep.2022.07.014. Epub 2022 Sep 28.
Alkhouli M, Russo AM, Thaler D, Windecker S, Anderson JA, Gage R, Lakkireddy D. Sex Differences in Safety and Effectiveness of LAAO: Insights From the Amulet IDE Trial. JACC Cardiovasc Interv. 2022 Nov 14;15(21):2143-2155. doi: 10.1016/j.jcin.2022.06.037. Epub 2022 Oct 12.
Price MJ, Ellis CR, Nielsen-Kudsk JE, Thaler D, Gupta N, Koulogiannis K, Anderson JA, Gage R, Lakkireddy D. Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial. JACC Cardiovasc Interv. 2022 Nov 14;15(21):2127-2138. doi: 10.1016/j.jcin.2022.09.001.
Lakkireddy D, Thaler D, Ellis CR, Swarup V, Sondergaard L, Carroll J, Gold MR, Hermiller J, Diener HC, Schmidt B, MacDonald L, Mansour M, Maini B, O'Brien L, Windecker S. Amplatzer Amulet Left Atrial Appendage Occluder Versus Watchman Device for Stroke Prophylaxis (Amulet IDE): A Randomized, Controlled Trial. Circulation. 2021 Nov 9;144(19):1543-1552. doi: 10.1161/CIRCULATIONAHA.121.057063. Epub 2021 Aug 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SJM-CIP-10114
Identifier Type: -
Identifier Source: org_study_id
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