| Eligibility |
Inclusion Criteria:
1. The heart team recommends transcatheter valve aortic valve replace consistent with the
2017 ESC/EACTS Guidelines for the management of valvular heart disease.
2. 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.
3. 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.
4. 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.
5. Subject is a minimum of 18 years of age.
Exclusion Criteria:
General:
1. Left upper limb vasculature in the left extremity precluding 6Fr sheath radial /
brachial / subclavian access.
2. Inadequate circulation to the left extremity as evidenced by signs of artery occlusion
(modified Allen's test) or absence of radial/brachial pulse.
3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity
vasculature.
4. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical,
transaortic, carotid or transcaval).
5. Evidence of an acute myocardial infarction = 1 month before the intended treatment.
6. Aortic valve is a congenital unicuspid or bicuspid valve.
7. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant
aortic regurgitation >3+).
8. 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).
9. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of
bleeding diathesis or coagulopathy.
10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
11. Need for emergency surgery for any reason.
12. Severe hypertrophic cardiomyopathy with or without obstruction.
13. Severe ventricular dysfunction with LVEF =30%.
14. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.
15. Symptomatic or asymptomatic severe (= 70%) occlusive carotid disease requiring
concomitant CEA / stenting.
16. Subject has undergone carotid stenting or carotid endarterectomy within the previous 6
weeks.
17. Active peptic ulcer or upper GI bleeding within the prior 6 months.
18. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or
clopidogrel, device component material, or sensitivity to contrast media, which cannot
be adequately premedicated.
19. Recent (within 6 months) CVA or a TIA.
20. Renal insufficiency (creatinine > 3.0 mg / dL or GFR < 30) and / or renal replacement
therapy at the time of screening.
21. Life expectancy < 12 months due to non-cardiac co-morbid conditions.
22. Subjects in whom anti-platelet and / or anticoagulant therapy is contraindicated, or
who will refuse transfusion.
23. Subjects who have active bacterial endocarditis or other active infections.
24. Currently participating in an investigational drug or another device study.
25. Subjects who have a planned treatment with any other investigational device or
procedure during the study follow-up period (30 days).
26. Subjects with planned concomitant surgical or transcatheter ablation for Atrial
Fibrillation during the study follow-up period (30 days).
27. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure.
28. Subject is a woman of child-bearing potential.
29. Patient with Heparin-Induced Thrombocytopenia Syndrome.
30. Inner diameter of aortic arch is less than 25mm.
31. Brachiocephalic trunk originating from the aortic arch that splits into the bilateral
subclavian arteries and a bicarotid trunk (Origin D).
32. Hepatic failure (defined as liver enzyme elevations two times the upper limit of
normal) or active infectious hepatitis
33. Cardiogenic shock or severe hypotension (systolic blood pressure < 90 mm Hg) at the
time of the index procedure
34. Subjects who have a planned concomitant cardiac surgical or interventional procedure
(e.g., coronary revascularization) during the TAVI procedure
35. Subjects who have a pre-existing prosthetic heart valve in any position
Neurological:
1. Subject had active major psychiatric disease.
2. Subject has severe visual, auditory, or learning impairment and is unable to
comprehend English or local language and therefore unable to be consented for the
study.
3. Subjects with neurodegenerative or other progressive neurological disease or history
of significant head trauma followed by persistent neurologic defaults or known
structural brain abnormalities.
Angiographic:
1. Excessive tortuosity or severe peripheral arterial disease in the left radial /
brachial / subclavian artery preventing ProtEmbo System access and insertion.
2. Subject whose left radial / brachial / subclavian artery reveals significant stenosis,
calcification, ectasia, dissection, occlusion or aneurysm, in particular at or within
3 cm of the aortic ostium.
3. Subject with significant stenosis, ectasia, dissection, or aneurysm in the ascending
aorta or in the aortic arch, or with abnormal aortic arch angulation or abnormal
anatomical conditions of the aorta.
Magnetic Resonance Imaging:
1. Subject Body Mass Index (BMI) precluding imaging in scanner.
2. Contraindications to MRI (subjects with any implantable temporary or permanent
pacemaker or defibrillator, metal implants in field of view, metallic fragments,
clips, or devices in the brain or eye before TAVR procedure).
3. Subjects who have a high risk of complete AV block after TAVR, with the need of
permanent pacemaker (e.g. subjects with preexisting bifascicular block or complete
right bundle branch block plus any degree of AV block).
4. Planned implantation of a pacemaker or defibrillator implantation within the first 4
days after TAVR.
5. Claustrophobia precluding MRI scanning.
6. No scanner hardware, software, coil or protocol changes during the course of the
study.
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