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Sponsored by: |
CarboMedics Inc. |
Information provided by: | CarboMedics Inc. |
ClinicalTrials.gov Identifier: | NCT00619151 |
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.
Condition | Intervention |
Aortic Valve Disease |
Device: Top Hat Aortic Valve (CarboMedics) Device: St. Jude Medical Regent |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-Annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position. |
Estimated Enrollment: | 320 |
Study Start Date: | December 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
CarboMedics Supra-annular Top Hat Valve
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Device: Top Hat Aortic Valve (CarboMedics)
Study to compare sizing, implant techniques, and hemodynamics of the CarboMedics Top Hat supra-annular valve as compared to the St. Jude Medical Regent valve.
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2: Active Comparator
St. Jude Medical Regent Valve
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Device: St. Jude Medical Regent
Study to compare sizing, implant techniques, and hemodynamics of the Top Hat supra-annular valve as compared to the St. Jude Medical Regent valve.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |||||
Johns Hopkins Hospital | |||||
Baltimore, Maryland, United States, 21287 | |||||
United States, Tennessee | |||||
Wellmont Holston Valley Medical Center | |||||
Kingsport, Tennessee, United States, 37660 |
CarboMedics Inc. |
Responsible Party: | Sorin Group ( Barbara Mathews, RN, MSN / Senior Director Clinical Research CVH ) |
Study ID Numbers: | RVSS-1H |
First Received: | January 10, 2008 |
Last Updated: | June 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00619151 |
Health Authority: | United States: Institutional Review Board |
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