Use of Cardiac-MRI to Predict Results for People With Severe Aortic Stenosis

Aortic valve stenosis is a disease that causes narrowing of a major heart valve, and that
reduces heart function and causes death. The purpose of this protocol is to use magnetic
resonance imaging of the heart to identify which patients would benefit from replacement of
the diseased valve.

- INCLUSION CRITERIA:

Subjects must meet all the following inclusion criteria prior to enrollment into the
trial:

1. Severe aortic stenosis defined as aortic valve area of less than 1 cm(2) or index
area of 0.6 cm(2)/m(2) by echocardiography.

2. Symptomatic patients with aortic stenosis referred for medically indicated AVR

3. LV EF less than or equal to 0.50

4. Signed informed consent to participate in the study.

Specific criteria for MR perfusion sub-study:

5. Absence of any significant coronary lesions or presence of coronary disease for
conservative (medical) therapy< TAB> .

EXCLUSION CRITERIA:

1. Inability to sign written informed consent.

2. Subjects with contraindication to MRI scanning, including the following devices or
conditions:

- Cardiac pacemaker or implantable defibrillator

- Cerebral aneurysm clip

- Neural stimulator (e.g. TENS-Unit)

- Any type of ear implant

- Ocular foreign body (e.g. metal shavings)

- Any implanted device (e.g. insulin pump, drug infusion device)

- Metal shrapnel or bullet.

- Atrial fibrillation

3. Subjects with a known hypersensitivity, allergy or contraindication to iodine or
gadolinium

4. Impaired renal excretory function, calculated as Glomerular Filtration Rate (GFR) <
30mL/min/1.73m(2).

5. Contraindications for intravenous adenosine infusion:

- Known hypersensitivity to adenosine

- Known or suspected significant bronchoconstrictive or bronchospastic disease

- 2nd or 3rd degree atrioventricular (AV) block unless with permanent pacemaker

- Sinus bradycardia (heart rate < 45 bpm) unless with permanent pacemaker

- Systemic arterial hypotension (< 90 mmHg)

6. Presence of any coexisting severe valvular disorder.

7. Pregnancy or breast feeding (women of childbearing potential will have a serum or
urine pregnancy test).

8. Need for emergency surgery for any reason.

9. Any case in which the practicing physician asserts that enrollment in the protocol
will adversely affect the patient treatment course.

Specific exclusion criteria for MR perfusion sub-study:

No detectable reversible ischemia on pre-treatment/procedure cardiac MRI.

Subject underwent transcatheter AVR as part of one of the transcatheter heart valve trials
(i.e. PARTNER trial or the pivotal CoreValve trial).