Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT00705913
First received: June 18, 2008
Last updated: January 6, 2012
Last verified: November 2011
  Purpose

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.


Condition Intervention
Aortic Valve Disease
Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Device: Carpentier-Edwards Magna Tissue Valve

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Sorin Group USA, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 368
Study Start Date: June 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00705913

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

No publications provided

Responsible Party: Sorin Group USA, Inc.
ClinicalTrials.gov Identifier: NCT00705913     History of Changes
Other Study ID Numbers: MRVSS-02
Study First Received: June 18, 2008
Last Updated: January 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sorin Group USA, Inc.:
aortic valve
heart valve
valve replacement
valve disease

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014