Status:
TERMINATED
Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Minimally-invasive operative techniques have been introduced in cardiac surgery. These techniques may have several advantages such as a decrease in post operative pain, lower morbidity and mortality, ...
Detailed Description
Background: Minimally invasive techniques for cardiac surgery should be formally evaluated. Design: Randomized, single-blind, monocentric trial. Interventions Compared: Median sternotomy versus m...
Eligibility Criteria
Inclusion
- Indication of isolated aortic valvular replacement
- Preoperative ASA class \< = 3
- Left ventricular ejection fraction \> = 40%
- Signed informed consent
Exclusion
- Aortic or mitral insufficiency \> 3
- History of cardiac surgery
- Acute pulmonary edema
- Endocarditis
- Chronic renal insufficiency decompensation
- Operative coagulation disorders regardless of etiology
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00221663
Start Date
January 1 2002
End Date
December 1 2006
Last Update
August 15 2008
Active Locations (1)
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1
Hôpital Cardiologique du Haut Lévêque
Pessac, France, 33604