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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Mitroflow Aortic Pericardial Heart Valve (CarboMedics) |
|
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitroflow Aortic Pericardial Heart Valve (CarboMedics) | Device | Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Pericardial valve as compared to the Edwards Magna valve |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States | ||
| Pepin Heart Hospital |
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| Carpentier-Edwards Magna Tissue Valve | Device | Study to compare sizing, implant techniques and hemodynamics of the Mitroflow Valve as compared to the Edwards Magna valve |
|
| Tampa |
| Florida |
| 33613 |
| United States |
| St. Luke's Medical Center | Kansas City | Kansas | 64111 | United States |
| Peninsula Regional Medical Center | Salisbury | Maryland | 21801 | United States |
| St. John's Medical Research Inst. | Springfield | Missouri | 65807 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| St.Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Hopital Laval | Sainte-Foy | Quebec | G1V 6G5 | Canada |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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