REST Study: Left Ventricular Regression European Study

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00256165
First received: November 16, 2005
Last updated: March 30, 2009
Last verified: March 2009
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Left Ventricular Regression European Study

Resource links provided by NLM:


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
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Tissue valve
    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

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe Bailleul, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00256165     History of Changes
Other Study ID Numbers: CS04009TV
Study First Received: November 16, 2005
Last Updated: March 30, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by St. Jude Medical:
Aortic valve replacement

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on April 17, 2014