| Eligibility |
Inclusion Criteria:
1. The heart team recommends transcatheter aortic valve replacement via femoral access
consistent with the 2020 ACC/AHA Guideline for the Management of Patients With
Valvular Heart Disease.
2. 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.
3. 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.
4. Subject is a minimum of 18 years of age.
Exclusion Criteria:
General exclusion criteria:
1. Subject is a woman of child-bearing potential.
2. Arm anatomy/ vasculature precluding radial or brachial artery access.
3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity
vasculature.
4. Evidence of an acute myocardial infarction = 1 month before the intended treatment.
5. Severe ventricular dysfunction with LVEF =25%.
6. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is
performed within 10 days of the index procedure.
7. Blood dyscrasias as defined by clinically significant leukopenia (< 500 leukocytes /
µL), acute anemia (Hgb < 8 g / dL), thrombocytopenia (< 80,000 platelets / µl),
history of bleeding diathesis or coagulopathy.
8. Hemodynamic instability, or pressure dependence requiring pharmacological inotropic
support or mechanical heart assistance.
9. Echocardiographic evidence of intracardiac or aortic mass, thrombus not adequately
treated, or vegetation.
10. Active peptic ulcer or upper GI bleeding within the prior 6 months.
11. Contraindication for anticoagulant or antiplatelet therapy.
12. Renal insufficiency (creatinine > 3.0 mg / dL or GFR < 30) and / or renal replacement
therapy at the time of screening and dialysis patients.
13. Current or planned treatment with any investigational drug or investigational device
during the study follow-up period (30 days).
14. Balloon aortic valvuloplasty (BAV) within 30 days of the procedure.
15. Cardiogenic shock, hemodynamic instability, or severe hypotension (systolic blood
pressure < 90 mm Hg) at the time of the index procedure.
16. Cardiovascular surgical or interventional procedure 10 days prior or planned during
the TAVR procedure or during the 30-day study follow-up.
17. Patients with severe chronic obstructive pulmonary disease (COPD)
NOTE: Use of general anesthesia during TAVR may affect neurocognitive function shortly
after the procedure. While not an exclusion criterion, it is recommended that general
anesthesia not be used if possible.
Neurological exclusion criteria:
1. Cerebrovascular event including TIA within 6 months of the procedure.
2. Subject had active major psychiatric disease.
3. 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.
4. Subjects with neurodegenerative or other progressive neurological disease or history
of significant head trauma followed by persistent neurologic defaults or known
structural brain abnormalities.
Magnetic resonance imaging exclusion criteria:
1. 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. High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g.,
subjects with pre-existing 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 3
days after TAVR.
5. Claustrophobia precluding MRI scanning.
Anatomical and CT exclusion criteria:
1. Excessive tortuosity in left subclavian artery (= 70° single kink or = 50° in
sequential kinks).
2. Excessive tortuosity in right vascular access vessels for Sentinel introduction.
3. Significant stenosis (= 70%), calcification, ectasia, dissection, occlusion, aneurysm,
or severe peripheral arterial disease in left or right arm access vessels - in
particular at or within 3 cm of the aortic ostia.
4. Left subclavian artery diameter is = 4 mm.
5. Brachiocephalic artery at the site of Sentinel filter placement < 9 mm or > 15 mm.
6. Left common artery at the site of Sentinel filter placement < 6.5 mm or > 10 mm.
7. Symptomatic or asymptomatic severe (= 70%) occlusive carotid disease requiring
concomitant CEA / stenting.
8. Inner diameter of aortic arch < 25 mm as measured in any position between ascending
aorta and ostium of left subclavian artery.
9. Distance between the origin of left subclavian artery and valve plain of < 90 mm.
10. Common ostium of cerebral vessels, where all three vessels originate from one single
ostium in the aortic arch.
11. Significant stenosis, ectasia, dissection, aneurysm, or atheroma (mobile or > 5 mm
thick) in the ascending aorta or in the aortic arch.
12. Significant angulation of the proximal segment of the left subclavian or aortic arch
angulation or abnormal anatomical conditions of the aorta (a Type 3 aortic arch is not
a reason for exclusion).
13. Distance between the origin of brachiocephalic trunk and left subclavian artery of >
65 mm.
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