Feasibility Study of the transShield Embolic Protection System

Ki vehet részt

• Patient is ≥18 years old
• Patient is scheduled for percutaneous TAVR using a commercial TAVR system
• Patient meets indications for TAVR per the device IFU
• The diameter of the artery at the site of the filter placement is ≤ 42 mm
• Size and condition of the femoral artery iliac arteries are appropriate for the 10F transShield Introducer
• Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
• Patient is willing and able to complete follow-up requirement

Ki nem vehet részt

• History of stroke or transient ischemic attack (TIA) within prior 6 months
• Evidence of an acute myocardial infarction (MI) within 30 days prior to study procedure
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
• Planned other cardiac surgical procedure within 2 weeks prior to or planned cardiac surgical or interventional procedure within 30 days after the TAVR procedure; Note: Diagnostic cardiac catheterization is permitted within 10 days prior to the TAVR procedure
• Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred
• A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
• Renal disease requiring chronic dialysis at time of treatment
• Severe pulmonary hypertension and right ventricular (RV) dysfunction
• Life expectancy <12 months due to non-cardiac co-morbid conditions
• Evidence of active systemic or local groin infection
• Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or severe atheroma (especially with calcification and surface irregularities) of the thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
• Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, ticlopidine, or clopidogrel, and/or contrast agents, that cannot be managed with premedication
• Known allergy to any device component
• History of bleeding diathesis or in whom anticoagulant and/or anti- platelet therapy is contraindicated, patients who will refuse transfusion, or have an active peptic ulcer or upper GI bleeding within the prior 3 months
• Severe left ventricular (LV) dysfunction with LV ejection fraction (LVEF) <20%
• Patient not undergoing TAVR via the trans-femoral route
• Carotid artery stenosis > 70% in either carotid artery
• Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
• Aortic valve is a congenital unicuspid valve or is non-calcified
• Predominant aortic regurgitation >3+
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation
• Known or suspected to be pregnant or lactating
• Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating