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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014