J-Valve Transfemoral Pivotal Study

Exclusion Criteria41

• Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
• Aortic valve stenosis \> moderate\*
• Severe mitral valve or tricuspid valve regurgitation\*
• Severe mitral valve or tricuspid valve stenosis\*
• Active infection, including infective endocarditis
• Cardiac imaging evidence of cardiac mass, thrombus or vegetation
• Inability to tolerate or a condition precluding treatment with antithrombotic (antiplatelet, anticoagulant) therapy
• Renal insufficiency (eGFR \<30 mL/min/1.73m\^2) or end stage renal disease requiring chronic dialysis
• Liver disease (cirrhosis of the liver \[Child-Pugh Class B or C\])
• Blood dyscrasias as defined: leukopenia (WBC \<3000 cells/mcL), thrombocytopenia (platelet count \<50,000 cells/mcL), anemia (hemoglobin \<9 g/dL), history of bleeding diathesis coagulopathy, or hypercoagulable state (unless therapeutically stable)
• Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, clopidogrel, Nitinol (Nickel, Titanium) or sensitivity to contrast media, which cannot be adequately premedicated
• Left ventricular dysfunction with left ventricular ejection fraction (LVEF) \<25% as measured by resting echocardiogram (or by CMR, when performed)\*
• Clinically significant untreated coronary artery disease requiring revascularization or anticipated coronary revascularization procedure within 12-months post index procedure
• Acute myocardial infarction within 30 days prior to index procedure
• PCI within 30 days prior to index procedure
• Carotid intervention within 6 weeks prior to index procedure or carotid artery disease requiring intervention
• Previous, or planned, other surgical or interventional procedures within 30 days before, during, or within 30 days after the index procedure
• Uncontrolled atrial fibrillation
• Severe right ventricular (RV) dysfunction\*
• Pulmonary hypertension (systolic PA pressure \>70mmHg or systolic PA pressure ≥2/3 of systemic systolic BP)
• Severe chronic obstructive pulmonary disease (COPD) requiring chronic oral steroids or requiring continuous home O2
• Stroke (CVA), transient ischemic attack (TIA) or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to index procedure
• Cardiogenic shock defined as systolic blood pressure \<90 mmHg in addition to signs of tissue hypoperfusion or the need for vasopressors and/or mechanical hemodynamic support to maintain systolic blood pressure ≥90mmHg
• Patient requires mechanical circulatory support within 30 days prior to index procedure
• Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
• Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
• Participation in another investigational study that has not reached its primary endpoint
• Considered to be part of a vulnerable population
• As assessed by Imaging Core Laboratory
• Anatomic Exclusions:
• Ascending Aortic diameter \>5 cm\*
• Aortic Annulus Perimeter \<57 mm or \>104 mm\*
• Inappropriate anatomy for femoral introduction and delivery of the study system
• Left ventricular end-diastolic diameter (LVEDD) \>75 mm\*
• Congenital aortic valve disease including Unicuspid, Bicuspid, or Quadricuspid aortic valve anatomy\*
• Congenital univentricle or other condition that, in the opinion of the investigator and/or consulting physician, may constitute an unwarranted surgical risk
• Excessive aortic valve prolapse that would preclude proper seating of the implant in the aortic annulus
• Abdominal/thoracic aortic aneurysm ≥5.0 cm\*
• Aorto-iliac disease requiring intervention to facilitate delivery of access sheath
• Excessive tortuosity of delivery system pathway, defined as severe tortuosity of multiple vessels including iliofemoral, thoracoabdominal aorta, aortic arch, or LV-aortic root angle \>80⁰
• As assessed by Imaging Core Laboratory