Status:
TERMINATED
Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna
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 sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.
Detailed Description
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 diameter...
Eligibility Criteria
Inclusion
- 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
- Less than 18 years of age
- Emergency Surgery
- Pre-existing valve prothesis in the aortic position
- Aortic root replacements or enlargements
- Active endocarditis
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00705913
Start Date
June 1 2008
End Date
September 1 2011
Last Update
January 9 2012
Active Locations (12)
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1
Sharp Memorial Hospital
San Diego, California, United States, 92123
2
Pepin Heart Hospital
Tampa, Florida, United States, 33613
3
St. Luke's Medical Center
Kansas City, Kansas, United States, 64111
4
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801