transShield Embolic Protection System Feasibility Study

This is an interventional treatment trial for Aortic Stenosis Read More

Inclusion Criteria:

• Patients must meet all of the following criteria to be eligible for participation in the study:

  • Patient is >18 years old
  • Patient is scheduled for percutaneous TAVR with up to 20French compatible commercial TAVR system
  • Patient meets indications for TAVR per the device Instructions For Use
  • The diameter of the artery at the site of the filter placement is between 28 mm and 42 mm
  • Size and condition of the femoral artery iliac arteries are appropriate for the 12French transShield Expandable Introducer and 20F Embolic Protection Device
  • 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 requirements

Exclusion Criteria:

• Patients must be EXCLUDED from participation in this study if any of the following criteria are met:

  • 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 or congenital bicuspid valve or is non-calcified
  • Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+)
  • A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
  • History of bleeding diathesis or in whom anticoagulant and/or anti-platelet therapy is contraindicated, patients who will refuse transfusion, or havean active peptic ulcer or upper GI bleeding within the prior 3 months
  • Renal insufficiency, defined as a creatinine level > 221μmol/L and/or end-stage renal disease requiring chronic dialysis at time of treatment
  • History of stroke or transient ischemic attack (TIA) within prior 6 months
  • Evidence of an acute myocardial infarction (MI) within prior 30 days
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within prior 30 days
  • Hypertrophic cardiomyopathy with or without obstruction
  • Need for emergency surgery for any reason
  • Severe left ventricular (LV) dysfunction with LV ejection fraction (LVEF) <20%
  • Severe pulmonary hypertension and right ventricular (RV) dysfunction
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • 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 narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta
  • Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, or sensitivity to contrast media, that cannot be managed with premedication
  • 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
  • Neurodegenerative or other progressive neurological disease
  • Known allergy to any device component
  • Known or suspected to be pregnant or lactating
  • Currently enrolled in an investigational drug or device clinical study in which the primary endpoint has not occurred
  • Patient has other medical, social or psychological problem that in the opinion of the investigator precludes them from participating