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AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE)

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ClinicalTrials.gov Identifier: NCT02879448
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stroke Device: Amulet Left Atrial Appendage Occluder Device: WATCHMAN Left Atrial Appendage Closure Not Applicable

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1878 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: AMPLATZER™ Amulet™ Left Atrial Appendage Occluder Randomized Controlled Trial
Study Start Date : August 2016
Actual Primary Completion Date : December 2020
Estimated Study Completion Date : May 2024
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Procedure-related complications, all-cause death, major bleeding [ Time Frame: 12-month ]
    The primary safety endpoint is a composite of procedure-related complications, or all-cause death, or major bleeding through 12 months

  2. Ischemic stroke, systemic embolism [ Time Frame: 18-month ]
    The primary efficacy endpoint is a composite of ischemic stroke or systemic embolism through 18 months

  3. Device closure [ Time Frame: 45-days ]
    The primary mechanism of action endpoint is 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


Secondary Outcome Measures :
  1. All stroke, systemic embolism, or cardiovascular/unexplained death [ Time Frame: 18-month ]
    A composite of all stroke, systemic embolism, or cardiovascular/unexplained death at 18 months post-implant

  2. Major bleeding post-device implant [ Time Frame: 18-month ]
    Major bleeding rate at 18 months post-implant: defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 to 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. Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
  5. Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
  6. Implanted with a mechanical valve prosthesis
  7. 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)
  8. Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
  9. 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 (cardioversion, ablation, cataract surgery, etc.)
  10. Myocardial infarction (MI) within 90 days prior to randomization
  11. New York Heart Association Class IV Congestive Heart Failure
  12. Left ventricular ejection Fraction (LVEF) ≤30%
  13. 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
  14. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  15. History of idiopathic or recurrent venous thromboembolism
  16. Left atrial appendage is obliterated or surgically ligated
  17. Thrombocytopenia or anemia requiring transfusions
  18. 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)
  19. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
  20. Subject is pregnant or pregnancy is planned during the course of the investigation
  21. Active endocarditis or other infection producing bacteremia
  22. Subject has had a transient case of AF (i.e. never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
  23. Subjects with severe renal failure (estimated glomerular filtration rate <30ml/min/1.73m²
  24. Subject whose life expectancy is less than 2 years
  25. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879448


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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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
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02879448    
Other Study ID Numbers: SJM-CIP-10114
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
Non-valvular atrial fibrillation
Left Atrial Appendage