The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study

The study objectives are to assess the safety and clinical performance of the CoreValve™ Evolut R™ System in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement. These objectives will be accomplished by a prospective clinical study involving up to 60 implanted subjects among up to six study centers.

Inclusion criteria

• Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram.
• Estimated 30 day mortality risk of > 15% by study center Heart Team assessment,33 OR at least two cardiovascular surgeons from the study center deny surgery because of prohibitive operative risk, estimated to be a combined >50% risk of irreversible mortality or morbidity.
• Symptoms of aortic stenosis, and NYHA Functional Class II or greater.
• The subject meets the legal minimum age to provide informed consent based on local regulatory requirements, and has provided written informed consent as approved by the EC/IRB of the respective clinical site.
• The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion criteria

Clinical exclusion criteria:

• Subject has been offered SAVR but has declined.
• Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve).
• Known hypersensitivity or contraindication to Nitinol.
• Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states.
• Untreated clinically significant coronary artery disease requiring revascularization.
• Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.
• End stage renal disease requiring chronic dialysis of creatinine clearance < 20 cc/min.
• Ongoing sepsis, including active endocarditis.
• Any condition considered a contraindication to extracorporeal assistance.
• Any percutaneous coronary or peripheral interventional procedure with a bare metal stent performed within 30 days prior to Heart Team assessment, or within six months prior to Heart Team assessment for procedures with a drug eluting stents.
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within eight weeks of Heart Team Assessment .
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support.
• Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Gastrointestinal (GI) bleeding that would preclude anticoagulation.
• Subject refuses a blood transfusion.
• 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 12 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-ups exams.
• Currently participating in an investigational drug or another device study (excluding registries).
• Evidence of an acute myocardial infarction ≤30 days before the index procedure.
• Need for emergency surgery for any reason.
• Liver failure (Child-C).
• Subject is pregnant or breast feeding.

Anatomical exclusion criteria:

• Pre-existing prosthetic heart valve in any position.
• Mixed aortic valve disease (aortic stenosis with moderate or severe aortic regurgitation).
• Severe mitral regurgitation.
• Severe tricuspid regurgitation.
• Moderate or severe mitral stenosis.
• Hypertrophic obstructive cardiomyopathy.
• Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass thrombus or vegetation.
• Congenital bicuspid or unicuspid valve verified by echocardiography.