Medtronic Transcatheter Aortic Valve Replacement (TAVR) Low Risk Bicuspid Study

Ki vehet részt

• Severe aortic stenosis, defined as follows:; For symptomatic patients:; Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest; For asymptomatic patients:; Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec, or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR; Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR; Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%
• Patient is considered low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment
• Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits

Ki nem vehet részt

• Any percutaneous coronary or peripheral interventional procedure with a bare metal stent or drug eluting stent performed within 30 days prior to screening committee approval
• Currently participating in an investigational drug or another device study (excluding registries)
• Evidence of an acute myocardial infarction ≤30 days before the study procedure due to unstable coronary artery disease (WHO criteria)
• Need for emergency surgery for any reason
• Severe mitral regurgitation amenable to surgical replacement or repair
• Severe tricuspid regurgitation amenable to surgical replacement or repair
• Moderate or severe mitral stenosis amenable to surgical replacement or repair
• Significant ascending aortopathy requiring surgical repair
• Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve)
• A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated:; aspirin or heparin (HIT/HITTS) and bivalirudin; ticlopidine and clopidogrel; Nitinol (titanium or nickel); contrast media
• Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
• Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• Gastrointestinal (GI) bleeding that would preclude anticoagulation
• 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)
• Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
• Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
• Pre-existing prosthetic heart valve in any position
• Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
• Age less than 60 years
• Ongoing sepsis, including active endocarditis
• Subject refuses a blood transfusion
• Subject is pregnant or breast feeding
• Subject is legally incompetent, or otherwise vulnerable; Anatomical exclusion criteria:
• Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient
• Prohibitive left ventricular outflow tract calcification
• Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis
• Aortic annulus diameter of <18 or >30 mm
• Ascending aorta diameter > 4.5 cm; For transfemoral or transaxillary (subclavian) access:
• Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO 23R, 26R, 29 R mm TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV