Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 ≥ 2 for men and ≥ 3 for women
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
18 years of age or older, or the age of legal consent
Able and willing to return for required follow-up visits and assessments
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 (defined as \< 50,000 platelets per microliter (\<50 x 10\^9 /L)or anemia (defined as hemoglobin \< 10 g/dL) 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.
You may not be if
Requires long-term OAC therapy for a condition other than AF
Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following 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 P2Y12 platelet inhibitor for \>1 year post-randomization
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
Underwent catheter ablation for AF or atrial flutter within 60 days prior to 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)
