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Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Primary Purpose

Aortic Valve Disease

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Carpentier-Edwards Magna Tissue Valve
Sponsored by
Sorin Group USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease focused on measuring aortic valve, heart valve, valve replacement, valve disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sharp Memorial Hospital
  • Pepin Heart Hospital
  • St. Luke's Medical Center
  • Peninsula Regional Medical Center
  • St. John's Medical Research Inst.
  • Montefiore Medical Center
  • Duke University Hospital
  • The Ohio State University Medical Center
  • Hospital of the University of Pennsylvania
  • The Heart Hospital Baylor Plano
  • St.Boniface General Hospital
  • Hopital Laval

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Mitroflow Aortic Pericardial Heart Valve (CarboMedics)

Outcomes

Primary Outcome Measures

Determine which of the two valve types, the Mitroflow or Magna valve, will demonstrate lower pressure gradients relative to aortic annulus

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.

Full Information

First Posted
June 18, 2008
Last Updated
January 6, 2012
Sponsor
Sorin Group USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00705913
Brief Title
Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Study Start Date
June 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorin Group USA, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
aortic valve, heart valve, valve replacement, valve disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
Intervention Description
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve
Intervention Type
Device
Intervention Name(s)
Carpentier-Edwards Magna Tissue Valve
Intervention Description
Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pepin Heart Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
St. Luke's Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64111
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
St. John's Medical Research Inst.
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
St.Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Hopital Laval
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 6G5
Country
Canada

12. IPD Sharing Statement

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Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

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