The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

Subjects must meet ALL of the following criteria:

General Inclusion Criteria

1. The patient is a male or non-pregnant female ≥18 years of age

2. The patient meets indications for transcatheter aortic valve implantation (TAVI)

3. The patient is willing to comply with protocol-specified follow-up evaluations

4. The patient, or legally authorized representative, has been informed of the nature of
the study, agrees to its provisions and has provided written informed consent,
approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Potential Subjects will be excluded if ANY of the following criteria apply:

General Exclusion Criteria

1. Patients undergoing transcatheter aortic valve implantation (TAVI) via the
trans-axillary, trans-subclavian, or trans-aortic route

2. Patients undergoing transcatheter aortic valve implantation (TAVI) via the transapical
approach due to friable or mobile atherosclerotic plaque in the aortic arch

3. Patients with a previously implanted prosthetic aortic valve (i.e., planned
valve-in-valve transcatheter aortic valve implantation (TAVI))

4. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year
following index procedure. Female subjects of child-bearing potential must have a
negative pregnancy test done within 14 days prior to index procedure per site standard
test

5. Patients with known diagnosis of acute myocardial infarction (AMI) within 72 hours
preceding the index procedure (according to definition) or AMI >72 hours preceding the
index procedure, in whom Creatine Kinase (CK) and CK-MB have not returned to within
normal limits at the time of procedure, or patients who are currently experiencing
clinical symptoms consistent with new-onset AMI, such as nitrate-unresponsive
prolonged chest pain

6. Patients with a history of bleeding diathesis or coagulopathy or patients in whom
anti-platelet and/or anticoagulant therapy is contraindicated, patients who will
refuse transfusion, or patients with an active peptic ulcer or history of upper
gastrointestinal (GI) bleeding within the prior 3 months

7. Patients with known mental or physical illness or known history of substance abuse
that may cause non-compliance with the protocol, confound the data interpretation, or
is associated with a life expectancy of less than one year

8. Patients with severe allergy or known hypersensitivity or contraindication to aspirin,
heparin/bivalirudin, clopidogrel, nitinol, stainless steel alloy, and/or contrast
sensitivity that cannot be adequately pre-medicated

9. Patients with a history of a stroke or transient ischemic attack (TIA) within the
prior 6 months

10. Patients with renal failure (estimated Glomerular Filtration Rate [eGFR] <30 mL/min,
calculated from serum creatinine by the Cockcroft-Gault formula)

11. Patients with hepatic failure (Child-Pugh class C)

12. Patients with hypercoagulable states that cannot be corrected by additional
periprocedural heparin

13. Patients presenting with cardiogenic shock at the time of the index procedure

14. Patients with severe peripheral arterial, abdominal aortic, or thoracic aortic disease
that precludes delivery sheath vascular access

15. Patients in whom the aortic arch, innominate artery ostium, or proximal innominate
artery is heavily calcified, severely atheromatous, or severely tortuous

16. Patients with an innominate artery ostium diameter <10 mm or >25 mm

17. Patients with a transverse aortic diameter >43

18. Patients with anatomic irregularities of the innominate artery that could prevent
positioning of the TriGuard upper stabilizer and compromise stability of the device

19. Patients with any other condition that would prevent adherence to the TriGuard HDH
Instructions for Use

20. Patients with contraindication to cerebral MRI

21. Patients who have a planned treatment with any other investigational device or
procedure during the study period

22. Patients planned to undergo any other cardiac surgical or interventional procedure
(e.g., concurrent coronary revascularization) during the TAVI procedure or within 10
days prior to the TAVI procedure. NOTE: Diagnostic cardiac catheterization is
permitted within 10 day prior to the TAVI procedure