AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02879448 |
Recruitment Status :
Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : January 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke | Device: Amulet Left Atrial Appendage Occluder Device: WATCHMAN Left Atrial Appendage Closure | Not Applicable |
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 : | August 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Amulet
Amulet left atrial appendage occluder
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Device: Amulet Left Atrial Appendage Occluder
Transcatheter left atrial appendage closure |
Active Comparator: WATCHMAN (Control)
WATCHMAN left atrial appendage closure device
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Device: WATCHMAN Left Atrial Appendage Closure
Transcatheter left atrial appendage closure |
- 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
- Ischemic stroke, systemic embolism [ Time Frame: 18-month ]The primary efficacy endpoint is a composite of ischemic stroke or systemic embolism through 18 months
- 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
- 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
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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)
- 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 to and willing to return for required follow-up visits and examinations
Exclusion Criteria:
- 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
- Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
- Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
- 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 (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
- Resting heart rate >110 bpm
- 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.

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

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 |
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: | January 13, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Non-valvular atrial fibrillation Left Atrial Appendage |