REST Study: Left Ventricular Regression European Study - Full Text View

Purpose

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).

Condition	Intervention	Phase
Aortic Valve Stenosis	Device: Tissue valve	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Left Ventricular Regression European Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve [ Time Frame: At 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	January 2006
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Aortic valve replacement

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256165

Locations


Germany
	Städtlishes Klinikum Braunschweig
	Braunschweig, Germany, 38126

Sponsors and Collaborators

St. Jude Medical

Investigators


Principal Investigator:	G. Gerosa, Prof.	Policlinico Universitario Cardiovasculare - Padua - Italy

More Information

Responsible Party:	St. Jude Medical ( Christophe Bailleul )
Study ID Numbers:	CS04009TV
First Received:	November 16, 2005
Last Updated:	February 21, 2008
ClinicalTrials.gov Identifier:	NCT00256165
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency

Keywords provided by St. Jude Medical:

Aortic valve replacement

Study placed in the following topic categories:

Heart Diseases

Constriction, Pathologic

Aortic valve stenosis

Aortic Valve Stenosis

Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00256165