The preDIlatation in tRanscathEter aortiC Valve implanTation Trial

1. Diameter of >5mm for Evolut R and >6mm for CoreValve of the vessel.
2. Aortic valve diameter of ≥20mm and ≤29mm as measured by echo.
3. Ascending aorta diameter ≤ 43mm at the sinotubular junction.
4. 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.

5. STS score of ≥ 8 OR LogEuroSCORE> 20%, OR

   • 80 years old OR

   • 65 years old with 1 or 2 (but not more than two) from the following criteria:

     • Liver cirrhosis (Class A or B).
     • Pulmonary insufficiency: VMS\<1 liter.
     • Previous heart surgery (CABG, vascular surgery).
     • Porcelain aorta.
     • Pulmonary artery systolic pressure >60 mmHg and high risk for heart surgery.
     • Relapsing pulmonary embolism.
     • Right ventricular insufficiency.
     • Thoracic wall injuries that contraindicate an open heart surgery.
     • History of radiation therapy of the mediastinum.
     • Connective tissue disease that contraindicates an open heart surgery.
     • Frailty/cachexia.
6. Patients will be informed on the nature of the study and provide written consent.

Exclusion Criteria:

1. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin or heparin and bivalirudin, ticlopidine and clopidogrel, nitinol (titanium or nickel), contrast media
2. Ongoing sepsis, including active endocarditis.
3. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to Heart Team assessment.
4. Echocardiographic evidence of LV or LA thrombus.
5. Mitral or tricuspid valve insufficiency (> grade II).
6. Previous aortic valve replacement (mechanical or bioprosthetic).
7. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA).

8. Patients with:

   Femoral, iliac or aortic vascular disease (stenosis etc) that precludes the insertion of a transcatheter sheath.

   OR Symptomatic carotid or vertebral artery disease (> 70% stenosis).

9. The patient has a bleeding diathesis, coagulopathy or denies blood transfusion.
10. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions.
11. Creatinine clearance \< 20 ml/min.
12. Active gastritis or ulcer.
13. Pregnancy.
14. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%.
15. Unicuspid or bicuspid aortic valve.
16. Mixed aortic valve disease (aortic stenosis and aortic regurgitation> 2+).
17. Liver failure (Child-Pugh class C).
18. 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).
19. Extreme aortic valve calcification and calcific asymmetry (if semiquantitively measured: grade 4, Agatston score: grade 4 AgS>5000 AU).
20. Aortic valve area of \< 0.4 cm2.