Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: Mitroflow Aortic Pericardial Heart Valve (CarboMedics)
* Device: Carpentier-Edwards Magna Tissue Valve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve, heart valve, valve replacement, valve disease