AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Amulet Left Atrial Appendage Occluder; Device: WATCHMAN Left Atrial Appendage Closure

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.

• Study Type: Interventional
• Enrollment (Actual): 1878
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Wahroonga, New South Wales, Australia, 2076
      • Specialist Cardiology
  • Queensland
    • Greenslopes, Queensland, Australia, 4120
      • Greenslopes Private Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • St. Andrew's Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • HeartCare St John of God Wexford Medical Centre
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital (U of BC)
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montreal (Montreal Heart Inst.)
• Czechia
  • Central Bohemia
    • Prague, Central Bohemia, Czechia, 15030
      • Nemocnice Na Homolce
• Denmark
  • Arhus, Denmark, 8200
    • Skejby University Hospital
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
• Germany
  • Berlin, Germany, 12200
    • Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg
  • Bad-wur
    • Villingen-Schwenningen, Bad-wur, Germany, 78052
      • Kliniken Villingen-Schwenningen
  • Bavaria
    • Coburg, Bavaria, Germany, 96450
      • Klinikum Coburg GmbH
    • Munich, Bavaria, Germany, 81379
      • Internistisches Klinikum München SUD
  • Hesse
    • Frankfurt, Hesse, Germany, 60389
      • Cardioangiologisches Centrum am Bethanien Krankenhaus
    • Frankfurt, Hesse, Germany, 60389
      • CardioVaskuläres Centrum St. Katharinen
  • North Rhin
    • Essen, North Rhin, Germany, 45138
      • Elisabeth-Krankenhaus Essen GmbH
  • North Rhine
    • Bielefeld, North Rhine, Germany, 33617
      • Evangelisches Krankenhaus Bielefeld
    • Dusseldorf, North Rhine, Germany, 40225
      • Medizinische Einrichtungen der Universität Düsseldorf
  • Rhineland
    • Mainz, Rhineland, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Saxony
    • Leipzig, Saxony, Germany, 04289
      • Herzzentrum Leipzig GmbH
• Italy
  • Lombard
    • Milano, Lombard, Italy, 20132
      • Ospedale San Raffaele - Aritmologia
• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • St. Antonius Ziekenhuis
• Portugal
  • Lisbon
    • Lisboa, Lisbon, Portugal, 1649-035
      • Santa Maria Hospital
• Spain
  • Andalu
    • Huelva, Andalu, Spain, 21005
      • Hospital General Juan Ramon Jimenez
  • Andalusia
    • Sevilla, Andalusia, Spain, 41007
      • Hospital Universitario Virgen Macarena
  • Castile And Leon
    • Salamanca, Castile And Leon, Spain, 37007
      • Hospital Universitario de Salamanca
  • Catalonia
    • Barcelona, Catalonia, Spain, 08025
      • Hospital De La Santa Creu I Sant Pau
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universidad de Navarra
• Switzerland
  • Bern, Switzerland, 3010
    • Center Inselspital Bern
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC.
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner-University Medical Center Phoenix
    • Phoenix, Arizona, United States, 85016
      • Arizona Cardiovascular Research Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernards Medical Center
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • La Jolla, California, United States, 92037
      • Scripps Health
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90033-5313
      • USC University Hospital
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Sacramento, California, United States, 95817
      • University of California - Davis Medical Center
    • Sacramento, California, United States, 95819
      • Mercy Medical Group - Cardiology
    • San Diego, California, United States, 92123
      • San Diego Cardiac Center
    • Santa Monica, California, United States, 90404
      • Pacific Heart Institute
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates PC
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology Center
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • Fort Lauderdale, Florida, United States, 33316
      • Broward General Medical Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Medical Center
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queen's Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Naperville, Illinois, United States, 60540
      • Midwest Cardiovascular Institute
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center
    • Oakbrook Terrace, Illinois, United States, 60181
      • Advocate Health and Hospitals Corporation
  • Indiana
    • Indianapolis, Indiana, United States, 46240-0970
      • St. Vincent Hospital
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
    • Overland Park, Kansas, United States, 66211
      • Kansas City Cardiac Arrhythmia Research Foundation
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic Medical Center
    • Fall River, Massachusetts, United States, 02720
      • Charlton Memorial Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital, Royal Oak
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center Minneapolis
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital (Central MN Heart Clinic)
    • Saint Paul, Minnesota, United States, 55102
      • St. Joseph's Hospital
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
    • Hackensack, New Jersey, United States, 07601-1901
      • Hackensack University Medical Center
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Mineola, New York, United States, 11501
      • Winthrop-University Hospital
    • New York, New York, United States, 10016
      • New York University Hospital
    • New York, New York, United States, 10019
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • New York Presbyterian/Columbia University Medical Center
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Health & Hospitals
    • Winston-Salem, North Carolina, United States, 27157-1045
      • Wake Forest University Medical Center Clinical Sciences
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute at Utica
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital and Health Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Institute for Medical Research
    • York, Pennsylvania, United States, 17403-3676
      • WellSpan Health
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29401
      • Roper Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • St. Thomas Hospital
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt Heart Institute
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia
    • Austin, Texas, United States, 78756
      • Austin Heart
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital
  • Vermont
    • Burlington, Vermont, United States, 05405-0068
      • University of Vermont College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98107
      • Swedish Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older
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
5. 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)
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:

1. Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
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.

Echocardiographic Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amulet; Amulet left atrial appendage occluder	Device: Amulet Left Atrial Appendage Occluder; Transcatheter left atrial appendage closure
Active Comparator: WATCHMAN (Control); WATCHMAN left atrial appendage closure device	Device: WATCHMAN Left Atrial Appendage Closure; Transcatheter left atrial appendage closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 bleedingOvert 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 tamponadeBleeding requiring surgical intervention for (Watchman)Bleeding requiring intravenous vasoactive drugs; Type 3c:Intracranial hemorrhage including subdural hemorrhagesSubcategories confirmed by autopsy/imaging/lumbar punctureIntraocular bleed compromising vision; Type 5a: Probably fatal bleeding; Type 5b: Definite fatal bleeding	At 12-months
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.	At 18-months
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.	At 45-days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 18-months
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 bleedingOvert 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 tamponadeBleeding requiring surgical intervention for (Watchman)Bleeding requiring intravenous vasoactive drugs; Type 3c:Intracranial hemorrhage including subdural hemorrhagesSubcategories confirmed by autopsy/imaging/lumbar punctureIntraocular 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	At 18-months
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 bleedingOvert 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 tamponadeBleeding requiring surgical intervention for (Watchman)Bleeding requiring intravenous vasoactive drugs; Type 3c:Intracranial hemorrhage including subdural hemorrhagesSubcategories confirmed by autopsy/imaging/lumbar punctureIntraocular bleed compromising vision; Type 5a: Probably fatal bleeding; Type 5b: Definite fatal bleeding	At 12-months
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.	At 18-months
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.	At 45-days

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Dhanunjaya Lakkireddy, MD, University of Kansas; Study Chair: David Thaler, MD, PhD, The Comprehensive Stroke Center at Tufts Medical Center; Study Chair: Stephan Windecker, MD, PhD, Inselspital, University of Bern

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 24, 2016
• Primary Completion (Actual): December 7, 2020
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimated): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Left Atrial Appendage; Non-valvular atrial fibrillation
• Other Study ID Numbers: SJM-CIP-10114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO