REST Study: Left Ventricular Regression European Study
REST Study: Left Ventricular Regression European Study
The purpose of this study is to obtain data regarding the left ventricular mass (LVM)
 regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing
 LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with
 echocardiography (2-dimensional [2D] mandatory; 3-dimensional [3D] in sites where the
 technology is available).
Inclusion Criteria:

 -  Patient requires, for the first time, isolated aortic valve replacement due to aortic
 stenosis or mixed aortic stenosis disease etiology when aortic stenosis is predominant
 and aortic regurgitation is mild.

 -  Patient is of legal age in the host country.

 -  Patient (or legal guardian) has signed a study specific informed consent form

 Exclusion Criteria:

 -  Patient was previously operated on with any heart surgery including heart valve
 replacement or coronary artery bypass graft (CABG); or underwent any form of
 myocardial revascularization in the past (including stents), etc.

 -  Patient requires any concomitant heart surgery other than the isolated native aortic
 heart valve replacement and concomitant ascending aortic replacement (e.g not allowed
 are: multiple valve replacements or concomitant CABG, pacemaker insertions, or severe
 septal hypertrophy needing surgical excision, etc.)

 -  Patient has unstable angina

 -  Patient is in New York Heart Association functional class IV

 -  Patient has significant abnormality in wall motion

 -  Patient is affected by active endocarditis.

 -  Patient has a cardiac pacemaker or automatic implanted cardiac defibrillator

 -  Patient is affected by acute aortic dissection.

 -  Patient is in chronic and persistent atrial fibrillation

 -  Patient receives hemodialysis therapy

 -  Patient has a medical condition which contraindicates implantation of the SJM Epic and
 Epic™ Supra Porcine Bioprosthetic Heart Valve (e.g. renal failure or abnormal calcium
 metabolism).

 -  Patient has aneurysmal clips or carotid artery vascular stents

 -  Patient has a neurostimulator

 -  Patient has an implanted or external drug infusion device (e.g. insulin pump)

 -  Patient has a bone growth/fusion stimulator

 -  Patient has a cochlear, otologic, or ear implant

 -  Patients with severe claustrophobia in which medical sedation is contraindicated or
 unable to resolve anxiety sufficiently

 -  Patients with ocular foreign body (e.g. metal shavings)

 -  Patient is pregnant or nursing