Status:
UNKNOWN
Heart Leaflet Technologies Valve Study
Lead Sponsor:
Centro Cardiologico Monzino
Conditions:
Aortic Valve Stenosis
Endovascular Aortic Valve Replacement
Eligibility:
All Genders
75-80 years
Phase:
NA
Brief Summary
The study will be conducted in patients who are undergoing surgical aortic valve replacement on cardiopulmonary bypass. Following surgical access of the native aortic valve and prior to removal of the...
Detailed Description
Aortic valve stenosis is a disease in which the leaflets of the aortic valve become scarred and calcified. This leads to a severe narrowing of the valve orifice, which causes chest pain, heart failure...
Eligibility Criteria
Inclusion
- Patients undergoing aortic valve replacement for aortic valve stenosis with a preoperative valve area \< 0.9 cm2.
- A preoperative echocardiogram where the aortic annulus diameter can be measured and is between 19 and 25 mm internal diameter.
- Age 75 to 80 years
Exclusion
- Emergency valve surgery
- Significant ascending aortic disease (atheroma, extensive calcification, dissection) as assessed by the operating surgeon
- Ostial coronary obstruction \> 25% diameter stenosis
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00710775
Start Date
November 1 2007
End Date
December 1 2008
Last Update
October 12 2009
Active Locations (1)
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1
Centro Cardiologico Monzino- University of Milan, Italy
Milan, Italy, 20138