Status:
TERMINATED
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics
Lead Sponsor:
Sorin Group USA, Inc.
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center.
Exclusion
- Patients \< 18 years of age
- Emergency surgery
- Pre-existing valve prosthesis
- Aortic root replacement
- Active endocarditis
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00619151
Start Date
December 1 2007
End Date
May 1 2008
Last Update
November 16 2011
Active Locations (2)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States, 37660