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Study stopped due to lack of elegible patient enrollment
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The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | CarboMedics Supra-annular Top Hat Valve |
|
| 2 | Active Comparator | St. Jude Medical Regent Valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Top Hat | Device | Implant of CarboMedics Top Hat mechanical valve. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Orifice Area (EOA) | Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve. | 6 month evaluation |
| Aortic Mean Gradient | Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States | ||
| Wellmont Holston Valley Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Top Hat Valve | CarboMedics Supra-annular Top Hat Valve |
| FG001 | St.Jude Valve | St. Jude Medical Regent Valve |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Top Hat Valve | CarboMedics Supra-annular Top Hat Valve |
| BG001 | St.Jude Valve | St. Jude Medical Regent Valve |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effective Orifice Area (EOA) | Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve. | Analysis not performed due to study termination prior to analysis period. | Posted | Mean | Standard Deviation | cm^2 | 6 month evaluation |
|
Duration of hospital stay after surgery, an average of 4 days.
Adverse event information collected during hospital stay
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Top Hat Valve | CarboMedics Supra-annular Top Hat Valve |
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Early termination due to low enrollment resulted in only 2 patients. Insufficient data for analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Mathews Director Clinical and Medical Affairs | Sorin Group USA, Inc. | 512-435-3602 | Barbara.mathews@sorin.com |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Regent |
| Device |
Implant of the St. Jude Medical Regent mechanical valve |
|
| Kingsport |
| Tennessee |
| 37660 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Primary | Aortic Mean Gradient | Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve. | Analysis not performed due to study termination prior to analysis period. | Posted | Mean | Standard Deviation | mmHg | 6 months |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | St.Jude Valve | St. Jude Medical Regent Valve | 0 | 0 | 0 | 0 |
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