Clinical trial NCT00256165: REST Study: Left Ventricular Regression European Study
Official title: Left Ventricular Regression European Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Valve Stenosis
Keywords: Aortic valve replacement
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve
timeFrame: At 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Braunschweig
country: Germany
facility: Städtlishes Klinikum Braunschweig
Study officials:
affiliation: Policlinico Universitario Cardiovasculare - Padua - Italy
name: G. Gerosa, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Breitenbach I, Harringer W, Tsui S, Amorim MJ, Herregods MC, Bogaert J, Goiti JJ, Gerosa G. Magnetic resonance imaging versus echocardiography to ascertain the regression of left ventricular hypertrophy after bioprosthetic aortic valve replacement: results of the REST study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):640-645.e1. doi: 10.1016/j.jtcvs.2011.11.017. Epub 2011 Dec 10.