REST Study: Left Ventricular Regression European Study

February 1, 2019 updated by: Abbott Medical Devices

Left Ventricular Regression European Study

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).

Study Overview

Status

Completed

Conditions

Aortic Valve Stenosis

Intervention / Treatment

Device: Tissue valve

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Braunschweig, Germany, 38126
    - Städtlishes Klinikum Braunschweig

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)