REST Study: Left Ventricular Regression European Study

Phase 4

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT00256165
• Lead Sponsor: Abbott Medical Devices

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-16
• Study First Submitted QC: 2005-11-16
• Study First Posted: 2005-11-21
• Study Start: 2006-01
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The comparison of left ventricular mass index (LVMI) at 6 months between echocardiogram (echo) and MRI in patients implanted with an Epic valve	At 6 months

Trial Locations

Locations (1)

Städtlishes Klinikum Braunschweig; 🇩🇪 Braunschweig, Germany