Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

January 6, 2012 updated by: Sorin Group USA, Inc.

A Randomized Study to Compare Sizing, Implant Techniques and Hemodynamic Performance Between the Mitroflow and the Carpentier-Edwards Magna Pericardial Tissue Valves in the Aortic Position

The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Not Applicable

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St.Boniface General Hospital
    • Quebec
      • Sainte-Foy, Quebec, Canada, G1V 6G5
        • Hopital Laval
  • United States
    • California
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Tampa, Florida, United States, 33613
        • Pepin Heart Hospital
    • Kansas
      • Kansas City, Kansas, United States, 64111
        • St. Luke's Medical Center
    • Maryland
      • Salisbury, Maryland, United States, 21801
        • Peninsula Regional Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65807
        • St. John's Medical Research Inst.
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Hospital
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Texas
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.

Exclusion Criteria:

  • Less than 18 years of age
  • Emergency Surgery
  • Pre-existing valve prothesis in the aortic position
  • Aortic root replacements or enlargements
  • Active endocarditis

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Device: Carpentier-Edwards Magna Tissue Valve
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve
Active Comparator: 1
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate higher ratio of EOA to the aortic annulus area.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Sorin Group USA, Inc.

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

June 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 18, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 27, 2008

Study Record Updates

Last Update Posted (Estimate)

January 9, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRVSS-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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