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REST Study: Left Ventricular Regression European Study

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Tissue valve
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aortic Valve Stenosis focused on measuring Aortic valve replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Städtlishes Klinikum Braunschweig

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
November 16, 2005
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00256165
Brief Title
REST Study: Left Ventricular Regression European Study
Official Title
Left Ventricular Regression European Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Aortic valve replacement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Tissue valve
Intervention Description
Aortic valve replacement
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
G. Gerosa, Prof.
Organizational Affiliation
Policlinico Universitario Cardiovasculare - Padua - Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Städtlishes Klinikum Braunschweig
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22154789
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.
Results Reference
derived

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REST Study: Left Ventricular Regression European Study

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