Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Ki vehet részt

• Male or Female
• Age ≥ 65 years at time of consent
• Women of non-childbearing potential
• Severe degenerative calcific native aortic valve stenosis with the following criteria assessed either by resting or dobutamine stress TTE:; Aortic valve area (AVA) < 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and; Jet velocity > 4.0 m/s or mean gradient > 40 mmHg
• Symptomatic aortic stenosis (AS), defined as a history of at least one of the following:; Dyspnea that qualifies at NYHA class II or greater; Angina pectoris; Cardiac syncope
• Subject is considered at intermediate or high risk for surgical valve replacement based on at least one of the following:; EuroSCORE II ≥ 4% along with assessment of frailty, major organ system dysfunction, and procedure-specific impediments, in accordance with scientific guidelines; Agreement by the Heart Team that subject is at moderate to high operative risk of serious morbidity or mortality with surgical valve replacement
• The local Heart Team deems the patient to be eligible for transfemoral TAVI
• Perimeter-based aortic annulus diameter between ≥ 18 and ≤ 29 mm measured by computed tomography (CT) analyzed by a core lab
• Adequate iliofemoral access with either:; At least one side with minimum vessel diameter ≥ 6.0 mm and acceptable level of vessel calcification and tortuosity for safe placement of the introducer sheath, as analyzed by a core lab, OR; At least one side with minimum vessel diameter ≥ 5.5 and no significant calcification or severe tortuosity for safe placement of the introducer sheath, as analyzed by a core lab
• Patient (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent
• The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits

Ki nem vehet részt

• Evidence of an acute myocardial infarction (MI) ≤ 30 days prior to screening or IMD implantation (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation)
• Patient has had a cerebrovascular stroke or TIA within the past 90 days implantation prior to screening or valve implantation
• History of any therapeutic invasive cardiac procedure (including balloon aortic valvuloplasty) within 30 days prior to screening or IMD implantation (except for pacemaker implantation which is allowed)
• Patient has severe peripheral vascular disease:; including aortic aneurysm defined as maximal luminal diameter > 5 cm or with documented presence of thrombus, marked tortuosity, narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [> 5 mm], protruding or ulcerated atheroma in the aortic arch) or; symptomatic carotid or vertebral disease or successful treatment of carotid stenosis within 30 days prior to screening or IMD implantation
• Patient with active bacterial endocarditis within 6 months prior to screening or IMD implantation
• Patient has a need for emergency surgery for any reason at time of screening or IMD implantation; General:
• Patient with significant pulmonary disease (FEV1 < 30%) or currently on home oxygen
• Patient has peptic ulcer disease or history of gastrointestinal bleeding within the 3 months prior to screening or IMD implantation
• Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint (excluding observational studies)
• Untreated clinically significant coronary artery disease requiring revascularization at the screening visit
• Patient with cardiogenic shock manifested by low cardiac output and hemodynamic instability and vasopressor dependence, or mechanical hemodynamic support
• Patient has (echocardiographic/ CT and/or MRI) evidence of intra-cardiac mass, thrombus or vegetation
• Patient has a pre-existing prosthetic heart valve in any position (Note: mitral ring is not an exclusion)
• Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. patient with contraindication to oral antiplatelet therapy)
• Severe pulmonary hypertension (e.g., pulmonary artery systolic pressure ≥ 60 mmHg)
• Patients with evidence of an active systemic infection or sepsis
• Patient has a known hypersensitivity or contraindication to contrast media, bovine tissue, nitinol (titanium or nickel), contraindication to oral antiplatelet therapy (aspirin, ticlopidine or clopidogrel) or heparin
• Patient has a life expectancy of less than 12 months due to non-cardiac, co-morbid conditions based on the assessment of the investigator at the time of enrolment (i.e. the time of informed consent)
• Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
• Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the patient from appropriate consent or adherence to the protocol required follow-up exams
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography
• Patient with renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/ or renal replacement therapy and/ or has serum creatinine level > 3.0 mg/dL or 265 µmol/L replacement therapy at the time of screening
• Patient has a haemoglobin < 9 g/dL, platelet count < 50,000 cells/mm3 or > 700.000 cells/mm3, or white blood cell count < 1.000 cells/mm3, history of bleeding diathesis or coagulopathy
• Cardiovascular System:
• Patient has a congenital unicuspid or bicuspid aortic valve or non-calcified valves
• Patient has a hypertrophic obstructive cardiomyopathy
• Patients with clinically significant conduction abnormalities (clinically significant sinus bradycardia, sinus block or pauses, clinically significant atrioventricular (AV)-block >I) at screening and at time of IMD implantation
• Patient with iliofemoral vessel characteristics that would preclude safe passage of the introducer (both sides), as analyzed by a core lab:; severe calcification,; severe tortuosity (> two 90-degree bends),; diameter < 6 mm, in patients with acceptable levels of calcification and acceptable levels of tortuosity; diameter < 5.5, in patients with no calcification and no significant tortuosity, OR; subject has had an aorto-femoral bypass
• Patient has severe mitral regurgitation, severe aortic regurgitation or severe tricuspid regurgitation, moderate or severe mitral stenosis
• Patient refuses blood transfusions
• Patient is pregnant or breast feeding