AMPLATZER™ Amulet™ LAA Occluder Trial

Completed · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT02879448

Run by

Abbott Medical Devices

People needed

1878

Starts

2016-08-24

Expected to finish

2024-05-24

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 and willing to return for required follow-up visits and examinations

You may not qualify if…

• 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
• 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

Where it is running

• 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
• Heart Center Research, LLC. — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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