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AzTrials

StrokeAmulet IDENCT02879448

AMPLATZER™ Amulet™ LAA Occluder Trial

A study testing Amulet Left Atrial Appendage Occluder and WATCHMAN Left Atrial Appendage Closure in people with Stroke, run by Abbott Medical Devices at 115 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Amulet Left Atrial Appendage Occluder and WATCHMAN Left Atrial Appendage Closure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,878 participants
Where
115 sitesin 11 countries
Study dates
24 Aug 2016to 24 May 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
  • At high risk of stroke or systemic embolism defined as CHADS2 score ≥ 2 or a CHA2DS2-VASc score of ≥ 3
  • Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
  • Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation, following the conclusion of shared decision making (see inclusion criteria #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)
Show all 9Show fewer
  • Able to comply with the required medication regimen post-device implant
  • Able to understand and willing to provide written informed consent to participate in the trial
  • Able and willing to return for required follow-up visits and examinations

Who cannot join

  • Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
  • Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
  • Indicated for chronic P2Y12 platelet therapy inhibitor
  • 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).
  • 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
Show all 35Show fewer
  • Implanted with a mechanical valve prosthesis
  • 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)
  • 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, or intervention or surgery is planned within 60 days after implant procedure (e.g. cardioversion, ablation, cataract surgery, etc.)
  • Myocardial infarction (MI) within 90 days prior to randomization
  • New York Heart Association Class IV Congestive Heart Failure
  • Left ventricular ejection Fraction (LVEF) ≤30%
  • 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
  • Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  • History of idiopathic or recurrent venous thromboembolism
  • Left atrial appendage is obliterated or surgically ligated
  • Thrombocytopenia or anemia requiring transfusions
  • 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)
  • Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
  • Subject is pregnant or pregnancy is planned during the course of the investigation
  • Active endocarditis or other infection producing bacteremia
  • Subject has had a transient case of AF (i.e. never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
  • Subjects with severe renal failure (estimated glomerular filtration rate <30ml/min/1.73m²)
  • Subject whose life expectancy is less than 2 years
  • 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.
  • Echocardiographic Exclusion Criteria:
  • Intracardiac thrombus visualized by echocardiographic imaging
  • Existing circumferential pericardial effusion >2mm
  • Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm^2)
  • 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)
  • Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
  • Cardiac tumor
  • 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).
  • Placement of the device would interfere with any intracardiac or intravascular structure

Trial locations and contacts

115 sites in 11 countries.

115 sites in 11 countries

United States85 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Mission Health & Hospitals

    Asheville, North Carolina, 28801

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Texas Cardiac Arrhythmia

    Austin, Texas, 78705

  • Austin Heart

    Austin, Texas, 78756

  • Bradenton Cardiology Center

    Bradenton, Florida, 34205

  • Lahey Clinic Medical Center

    Burlington, Massachusetts, 01805

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405-0068

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Delray Medical Center

    Delray Beach, Florida, 33484

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Charlton Memorial Hospital

    Fall River, Massachusetts, 02720

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1901

  • The Queen's Medical Center

    Honolulu, Hawaii, 96813

  • The Methodist Hospital

    Houston, Texas, 77030

  • Heart Center Research, LLC.

    Huntsville, Alabama, 35801

  • St. Vincent Hospital

    Indianapolis, Indiana, 46240-0970

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Scripps Health

    La Jolla, California, 92037

  • Watson Clinic Center

    Lakeland, Florida, 33805

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • USC University Hospital

    Los Angeles, California, 90033-5313

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Baptist Hospital of Miami

    Miami, Florida, 33176

  • Aurora Medical Group

    Milwaukee, Wisconsin, 53215

  • Winthrop-University Hospital

    Mineola, New York, 11501

  • VA Medical Center Minneapolis

    Minneapolis, Minnesota, 55417

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • El Camino Hospital

    Mountain View, California, 94040

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540

  • St. Thomas Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt Heart Institute

    Nashville, Tennessee, 37212

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • New York University Hospital

    New York, New York, 10016

  • Mount Sinai Hospital

    New York, New York, 10019

  • New York Presbyterian/Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Advocate Health and Hospitals Corporation

    Oakbrook Terrace, Illinois, 60181

  • Kansas City Cardiac Arrhythmia Research Foundation

    Overland Park, Kansas, 66211

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Beaumont Hospital, Royal Oak

    Royal Oak, Michigan, 48073

  • University of California - Davis Medical Center

    Sacramento, California, 95817

  • Mercy Medical Group - Cardiology

    Sacramento, California, 95819

  • St. Cloud Hospital (Central MN Heart Clinic)

    Saint Cloud, Minnesota, 56303

  • St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • South Texas Cardiovascular Consultants

    San Antonio, Texas, 78201

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Pacific Heart Institute

    Santa Monica, California, 90404

  • Swedish Medical Center

    Seattle, Washington, 98107

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Oklahoma Heart Institute at Utica

    Tulsa, Oklahoma, 74104

  • North Mississippi Medical Center

    Tupelo, Mississippi, 38801

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

  • Wake Forest University Medical Center Clinical Sciences

    Winston-Salem, North Carolina, 27157-1045

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

  • WellSpan Health

    York, Pennsylvania, 17403-3676

Other trials in United States

Germany12 sites

  • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin, 12200

  • Evangelisches Krankenhaus Bielefeld

    Bielefeld, North Rhine, 33617

  • Klinikum Coburg GmbH

    Coburg, Bavaria, 96450

  • Medizinische Einrichtungen der Universität Düsseldorf

    Düsseldorf, North Rhine, 40225

  • Elisabeth-Krankenhaus Essen GmbH

    Essen, North Rhin, 45138

  • Cardioangiologisches Centrum am Bethanien Krankenhaus

    Frankfurt am Main, Hesse, 60389

  • CardioVaskuläres Centrum St. Katharinen

    Frankfurt am Main, Hesse, 60389

  • Asklepios Klinik St. Georg

    Hamburg, 20099

  • Herzzentrum Leipzig GmbH

    Leipzig, Saxony, 04289

  • UNIVERSITÄTSMEDIZIN der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland, 55131

  • Internistisches Klinikum München SUD

    Munich, Bavaria, 81379

  • Kliniken Villingen-Schwenningen

    Villingen-Schwenningen, Bad-wur, 78052

Other trials in Germany

Spain5 sites

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, Catalonia, 08025

  • Hospital General Juan Ramon Jimenez

    Huelva, Andalu, 21005

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca

    Salamanca, Castille and León, 37007

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41007

Other trials in Spain

Australia4 sites

  • St. Andrew's Hospital

    Adelaide, South Australia, 5000

  • Greenslopes Private Hospital

    Greenslopes, Queensland, 4120

  • HeartCare St John of God Wexford Medical Centre

    Murdoch, Western Australia, 6150

  • Specialist Cardiology

    Wahroonga, New South Wales, 2076

Other trials in Australia

Canada2 sites

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montreal, Quebec, H1T 1C8

  • Vancouver General Hospital (U of BC)

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Denmark2 sites

  • Skejby University Hospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Czechia1 site

  • Nemocnice Na Homolce

    Prague, Central Bohemia, 15030

Other trials in Czechia

Italy1 site

  • Ospedale San Raffaele - Aritmologia

    Milan, Lombard, 20132

Other trials in Italy

Netherlands1 site

  • St. Antonius Ziekenhuis

    Nieuwegein, Utrecht, 3435 CM

Other trials in Netherlands

Portugal1 site

  • Santa Maria Hospital

    Lisbon, Lisbon District, 1649-035

Other trials in Portugal

Switzerland1 site

  • Center Inselspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Read the detailed description

The Amulet IDE trial is a prospective, randomized, multi-center active control worldwide trial, designed to evaluate the safety and effectiveness of the AMPLATZER™ Amulet™ Left Atrial Appendage Occluder. Subjects will be randomized in a 1:1 ratio between the Amulet left atrial appendage (LAA) occlusion device (treatment) or a Boston Scientific WATCHMAN® LAA closure device (Control). The trial will be conducted at up to 150 sites worldwide. All enrolled subjects will follow the protocol-required tests and assessments at each scheduled follow-up visit.

Conditions
Stroke
Being tested
Amulet Left Atrial Appendage Occluder, WATCHMAN Left Atrial Appendage Closure
Keywords
Non-valvular atrial fibrillation, Left Atrial Appendage
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amulet Left Atrial Appendage OccluderDevice

    Transcatheter left atrial appendage closure

  • WATCHMAN Left Atrial Appendage ClosureDevice

    Transcatheter left atrial appendage closure

Study groups in NCT02879448
Study groupRoleWhat they receive
AmuletExperimentalAmulet left atrial appendage occluder
Receives: Device: Amulet Left Atrial Appendage Occluder
WATCHMAN (Control)Active comparatorWATCHMAN left atrial appendage closure device
Receives: Device: WATCHMAN Left Atrial Appendage Closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the Bleeding Academic Research Consortium (BARC) Definition) (Non-inferiority Analysis)

    Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention.

    All-cause deaths (cardiovascular or non-cardiovascular) were assessed.

    Major Bleeding

    • Type 3a:
    • Any transfusion with overt bleeding
    • Overt bleeding+Hb drop of ≥ 3 to < 5 g/dL (provided Hb drop is related to bleed)
    • Type 3b:
    • Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed)
    • Cardiac tamponade
    • Bleeding requiring surgical intervention for (Watchman)
    • Bleeding requiring intravenous vasoactive drugs
    • Type 3c:
    • Intracranial hemorrhage including subdural hemorrhages
    • Subcategories confirmed by autopsy/imaging/lumbar puncture
    • Intraocular bleed compromising vision
    • Type 5a: Probably fatal bleeding
    • Type 5b: Definite fatal bleeding

    Measured: At 12-months

  2. Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism (Non-inferiority Analysis)

    Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.

    Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.

    Measured: At 18-months

  3. Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)

    Device closure (defined as residual jet around the device ≤ 5 mm) at the 45-day visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler flow was assessed.

    Measured: At 45-days

Secondary outcomes (5)

  1. Composite Rate of All Stroke, Systemic Embolism, or Cardiovascular/Unexplained Death (Non-inferiority Analysis)

    Stroke: An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

    Systemic Embolism: Acute vascular insufficiency/occlusion of the extremities/any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (trauma/atherosclerosis/instrumentation). When there is presence of prior peripheral artery disease, angiographic/surgical/autopsy evidence is required to show abrupt arterial occlusion.

    Cardiovascular/unexplained death includes:

    • Death due to proximate cardiac cause
    • Death caused by non-coronary/non-CNS vascular conditions
    • Death from vascular CNS causes
    • All procedure-related deaths
    • Sudden/unwitnessed death
    • Death of unknown cause

    Measured: At 18-months

  2. Rate of Major Bleeding (Superiority Analysis)

    Major bleeding rate defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition was assessed

    • Type 3a:
    • Any transfusion with overt bleeding
    • Overt bleeding+Hb drop of ≥ 3 to < 5 g/dL (provided Hb drop is related to bleed)
    • Type 3b:
    • Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed)
    • Cardiac tamponade
    • Bleeding requiring surgical intervention for (Watchman)
    • Bleeding requiring intravenous vasoactive drugs
    • Type 3c:
    • Intracranial hemorrhage including subdural hemorrhages
    • Subcategories confirmed by autopsy/imaging/lumbar puncture
    • Intraocular bleed compromising vision
    • Type 5a: Probably fatal bleeding: bleeding that is clinically suspicious as the cause of death, but the bleeding is not directly observed and there is no autopsy or confirmatory imaging
    • Type 5b: Definite fatal bleeding: bleeding that is directly observed or confirmed on autopsy

    Measured: At 18-months

  3. Superiority Test of Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the Bleeding Academic Research Consortium (BARC) Definition)

    Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention.

    All-cause deaths (cardiovascular or non-cardiovascular) were assessed.

    Major Bleeding

    • Type 3a:
    • Any transfusion with overt bleeding
    • Overt bleeding+Hb drop of ≥ 3 to < 5 g/dL (provided Hb drop is related to bleed)
    • Type 3b:
    • Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed)
    • Cardiac tamponade
    • Bleeding requiring surgical intervention for (Watchman)
    • Bleeding requiring intravenous vasoactive drugs
    • Type 3c:
    • Intracranial hemorrhage including subdural hemorrhages
    • Subcategories confirmed by autopsy/imaging/lumbar puncture
    • Intraocular bleed compromising vision
    • Type 5a: Probably fatal bleeding
    • Type 5b: Definite fatal bleeding

    Measured: At 12-months

  4. Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism

    Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.

    Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.

    Measured: At 18-months

  5. Superiority Test of Primary Mechanism of Action Endpoint: Rate of Device Closure, by the Echocardiography Core Lab

    Device closure (defined as residual jet around the device ≤ 5 mm) at the 45-day visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler flow was assessed.

    Measured: At 45-days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2016 (estimated)
  2. Study start24 Aug 2016
  3. Primary completion7 Dec 2020
  4. Study completion24 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,878 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02879448
Sponsor's protocol ID
SJM-CIP-10114
Acronym
Amulet IDE
Status last verified
Jan 2025
First submitted
22 Aug 2016
Last updated
26 Feb 2025
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Schmidt B, Windecker S, Thaler D, Ellis CR, Nielsen-Kudsk JE, Freixa X, Aminian A, Anderson JA, Gage R, Alkhouli M, Lakkireddy D. Incidence, Predictors, Management, and Clinical Impact of Major Bleeding Following Left Atrial Appendage Occlusion: The Amulet IDE Randomized Clinical Trial. JAMA Cardiol. 2026 May 1;11(5):469-474. doi: 10.1001/jamacardio.2026.0336.

    PubMed 41879767

  • 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.

    PubMed 40208159

  • 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.

    PubMed 39570242

  • 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.

    PubMed 37587599

  • 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.

    PubMed 37584233

  • 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.

    PubMed 36697204

  • 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.

    PubMed 36357018

  • 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.

    PubMed 36357016

  • 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.

    PubMed 34459659

Questions about this trial

What is this clinical trial studying?

A study testing Amulet Left Atrial Appendage Occluder and WATCHMAN Left Atrial Appendage Closure in people with Stroke, run by Abbott Medical Devices at 115 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Germany, Spain, Australia, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint: Composite Endpoint Rate of Procedure-related Complications, or All-cause Death or Major Bleeding (Defined as Type 3 or Greater Based on the Bleeding Academic Research Consortium (BARC) Definition) (Non-inferiority Analysis) (time frame: At 12-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02879448, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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