Status:
COMPLETED
REST Study: Left Ventricular Regression European Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 measur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00256165
Start Date
January 1 2006
End Date
July 1 2008
Last Update
February 4 2019
Active Locations (1)
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1
Städtlishes Klinikum Braunschweig
Braunschweig, Germany, 38126