The PROTEMBO C Trial

Inclusion Criteria

• The heart team recommends transcatheter valve aortic valve replace consistent with the 2017 ESC/EACTS Guidelines for the management of valvular heart disease.
• Compatible left subclavian artery (≥ 4 mm diameter) without significant stenosis (> 70%) and distance between the origin of left subclavian artery and valve plain of ≥ 90mm as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality.
• The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits.
• The subject is able to provide informed consent, has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the relevant regulatory authority of the respective clinical site.
• Subject is a minimum of 18 years of age.

Exclusion Criteria

General:

• Left upper limb vasculature in the left extremity precluding 6Fr sheath radial / brachial / subclavian access.
• Inadequate circulation to the left extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/brachial pulse.
• Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
• TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment.
• Aortic valve is a congenital unicuspid or bicuspid valve.
• Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
• Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
• Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
• Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• Need for emergency surgery for any reason.
• Severe hypertrophic cardiomyopathy with or without obstruction.
• Severe ventricular dysfunction with LVEF ≤30%.
• Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.
• Symptomatic or asymptomatic severe (≥ 70%) occlusive carotid disease requiring concomitant CEA / stenting.
• Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks.
• Active peptic ulcer or upper GI bleeding within the prior 6 months.
• A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, device component material, or sensitivity to contrast media, which cannot be adequately premedicated.
• Recent (within 6 months) CVA or a TIA.
• Renal insufficiency (creatinine > 3.0 mg / dL or GFR < 30) and / or renal replacement therapy at the time of screening.
• Life expectancy < 12 months due to non-cardiac co-morbid conditions.
• Subjects in whom anti-platelet and / or anticoagulant therapy is contraindicated, or who will refuse transfusion.
• Subjects who have active bacterial endocarditis or other active infections.
• Currently participating in an investigational drug or another device study.
• Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (30 days).
• Subjects with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation during the study follow-up period (30 days).
• Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure.
• Subject is a woman of child-bearing potential.
• Patient with Heparin-Induced Thrombocytopenia Syndrome.
• Inner diameter of aortic arch is less than 25mm.
• Brachiocephalic trunk originating from the aortic arch that splits into the