Amplatzer Amulet LAAO vs. NOAC

STATUS

Recruiting
End date

Apr 28, 2029
participants needed

2650
sponsor

Abbott Medical Devices

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Updated on 19 February 2024

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stroke

vitamin k

vascular disease

electrocardiogram

vitamin

noac

embolism

vascular disorder

ischemic stroke

left atrial appendage occlusion

Summary

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy.

The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Details

Condition	Arrhythmia, Arrhythmia, Hemorrhage, Hemorrhage, Atrial Fibrillation, Atrial Fibrillation, Cerebrovascular accident
Age	18-100 years
Treatment	Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
Clinical Study Identifier	NCT04226547
Sponsor	Abbott Medical Devices
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
	At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of 3
	Eligible for long-term NOAC therapy
	Able to comply with the required NOAC medication regimen if randomized to the Control Group
	Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in
	Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment
	years of age or older, or the age of legal consent
	Able and willing to return for required follow-up visits and assessments
Exclusion Criteria
	Requires long-term OAC therapy for a condition other than AF
	Planned cardiac procedure, which is invasive or requires sedation or anesthesia, within 3 months of randomization (other than study-related procedures such as LAAO and cardiac imaging (if applicable))
	Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
	Indicated for chronic P2Y12 platelet inhibitor
	In the opinion of the investigator, is considered at high risk for general anesthesia and 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
	Is implanted with a mechanical valve prosthesis
	Is implanted with an inferior vena cava filter
	History of rheumatic or congenital mitral valve heart disease
	Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has active infection or bleeding disorder)
	Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer)
	Experienced 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 (e.g., cardioversion, ablation, cataract surgery, etc.) is planned within 60 days after randomization
	Experienced myocardial infarction within 90 days prior to randomization
	New York Heart Association Class IV Congestive Heart Failure
	Left ventricular ejection fraction 30% (per most recent assessment)
	Symptomatic carotid disease (defined as > 50% lumen diameter narrowing on CTA, MRA, or TCD 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% lumen diameter narrowing
	Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale)
	Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
	History of idiopathic or recurrent venous thromboembolism
	LAA is obliterated or surgically ligated
	Thrombocytopenia or anemia requiring transfusions
	Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy)
	Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial
	Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
	Active endocarditis or other infection producing bacteremia
	Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)
	Severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2), but not on dialysis
	Life expectancy is less than 2 years in the opinion of the Investigator
	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 investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results

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Amplatzer Amulet LAAO vs. NOAC