Abbott Medical - VERITAS Study

Korábbi kezelés

• Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to when Amulet 2 device implant procedure would occur (any intervention or surgery that utilized anesthesia, anesthetic, or sedation)
• Underwent catheter ablation for AF or atrial flutter within 60 days prior to when Amulet 2 device implant procedure would occur
• Experienced stroke or transient ischemic attack within 90 days prior to when Amulet 2 device implant procedure would occur
• Experienced myocardial infarction (with or without intervention) within 90 days prior to when Amulet 2 device implant procedure would occur
• Underwent prior attempted endocardial, epicardial, or surgical LAA closure or occlusion, defined as deployment of a device or surgical procedure whether successful or unsuccessful
• Actively enrolled in, or plans to enroll in, a concurrent clinical investigation in which the active treatment arm may confound the results of the VERITAS Study. Each instance must be brought to the attention of the Sponsor to determine eligibility.
• Transient case of AF (i.e., never previously detected, provoked/induced by surgical or catheter manipulations, etc.)

Más betegség

• Subject anatomy will not accommodate or is contraindicated for transesophageal echocardiography probe use (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer), or subject has experienced adverse events related to transesophageal echocardiography acquisition or has refused transesophageal echocardiography acquisition in the past
• Subject is planning any cardiac or non-cardiac intervention or surgery within 60 days after when Amulet 2 device implant procedure would occur (any intervention or surgery that utilized anesthesia, anesthetic, or sedation), except for study related activities
• New York Heart Association (NYHA) Class IV Congestive Heart Failure
• Known 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
• 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 within the past 5 years
• Known hypersensitivity to any portion of the device material or individual components of the Amulet 2 device (e.g., nickel allergy)
• Active endocarditis or other infection producing bacteremia
• Severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or on chronic dialysis
• 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.
  • Anatomical Exclusion Criteria:
• Inter-atrial communication (PFO/ASD with right to left shunt, if TEE performed) with an atrial septal aneurysm (excursion >15 mm or length ≥15 mm; excursion defined as maximal protrusion of the atrial septal aneurysm beyond the plane of the atrial septum) or large shunt (i.e., during Valsalva maneuver ≥20 bubbles of right-to-left shunt within 3 cardiac cycles after contrast media enters the right atrium, if TEE performed)
• Cardiac tumor

Laborértékek

• Required to take P2Y12 platelet inhibitor beyond 6 months when Amulet 2 LAA Occluder implant procedure would occur
• Left ventricular ejection fraction ≤30% (per most recent assessment)
• Thrombocytopenia (defined as < 50,000 platelets per microliter (<50 x 109/L) or anemia (defined as hemoglobin < 10 g/dL) requiring transfusions

Egyéb

• Is considered at high risk for general anesthesia in the opinion of the Investigator or based on past adverse reaction(s) requiring medical intervention or which resulted in prolongation of hospital stay
• Atrial septal defect or patent foramen ovale repair or occluder
• Implanted with a mechanical valve prosthesis
• Inpatient hospitalization due to clinical event or other sequelae within the past 7 days (i.e., not related to planned clinical study procedure or assessments)
• Inferior vena cava filter present
• Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation
• Life expectancy is less than 2 years in the opinion of the Investigator
• Intracardiac thrombus
• Existing circumferential pericardial effusion >2 mm
• Mitral valve stenosis, defined as a mitral valve area of <1.5 cm2
• Complex atheroma of the descending aorta and/or aortic arch, defined as plaque >4 mm in thickness, plaque ulceration, and/or mobile lesions
• LAA anatomy that cannot accommodate the Amulet 2 device, as per manufacturer's IFU (i.e., the LAA size must be within the sizing chart of the Amulet 2 device)
• Placement of the device would damage or interfere with the function of any intracardiac or intravascular structure

• Paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular AF and has not been diagnosed with rheumatic mitral valve disease
• CHA2DS2-VASc score of ≥2 for males or ≥3 for females
• Has an appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation
• Subject is eligible to stop anticoagulation if the LAA is sealed based on the implanting physician's opinion
• Subject is able to comply with the protocol defined pharmacologic regimen following Amulet 2 device implant (as described in Section 6.5)
• Subject is able to understand and willing to provide written informed consent to participate in the clinical investigation
• Subject is able and willing to return for required follow-up visits and protocol required clinical investigation activities
• 18 years of age or older, or the age of legal consent