REST Study: Left Ventricular Regression European Study

Abbott

Status and phase

Completed

Phase 4

Conditions

Aortic Valve Stenosis

Treatments

Device: Tissue valve

Study type

Interventional

Funder types

Industry

Identifiers

NCT00256165

CS04009TV

Details and patient eligibility

About

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).

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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