Conventional Versus Mini-Sternotomy for Aortic Valve Surgery
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|ClinicalTrials.gov Identifier: NCT00221663|
Recruitment Status : Terminated (slow recruitment)
First Posted : September 22, 2005
Last Update Posted : August 15, 2008
|Condition or disease||Intervention/treatment||Phase|
|Heart Valve Diseases||Device: surgery techniques (sternotomy for aortic valve replacement)||Phase 2 Phase 3|
Minimally invasive techniques for cardiac surgery should be formally evaluated.
Randomized, single-blind, monocentric trial.
Median sternotomy versus minimally invasive technique.
Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class < = 3, left ventricular ejection fraction > = 40%.
Forced expiratory volume and peak expiratory volume/second at 48 hours.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||January 2002|
|Actual Study Completion Date :||December 2006|
- Forced expiratory volume and peak expiratory volume/second [ Time Frame: at 48 hours ]
- Forced expiratory volume [ Time Frame: at 24 hours ]
- Peak expiratory volume/s at 24 hours
- Pro-inflammatory cytokines on tracheal aspiration samples
- Transfusion requirements during the first 24 hours post operative
- Hemodynamic parameters
- Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
- Consumption of analgetics
- Morbidity and mortality during hospital stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221663
|Hôpital Cardiologique du Haut Lévêque|
|Pessac, France, 33604|
|Principal Investigator:||Gerard Janvier, Pr||University Hospital, Bordeaux|
|Principal Investigator:||Joachim Calderon, Dr||University Hospital, Bordeaux France|
|Study Chair:||Geneviéve Chene, Pr||University Hospital, Bordeaux France|