A Phase 2/3 interventional study of surgery techniques (sternotomy for aortic valve replacement) in Heart Valve Diseases, sponsored by University Hospital, Bordeaux. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-15.
Sponsored by University Hospital, Bordeaux · Phase 2/3, Interventional, and Diagnostic
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, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.
Background:
Minimally invasive techniques for cardiac surgery should be formally evaluated.
Design:
Randomized, single-blind, monocentric trial.
Interventions Compared:
Median sternotomy versus minimally invasive technique.
Eligibility Criteria:
Indication of isolated aortic valvular replacement, preoperative American Society of Anesthesiologists (ASA) class \< = 3, left ventricular ejection fraction > = 40%.
Primary Outcome:
Forced expiratory volume and peak expiratory volume/second at 48 hours.
534 studies on the registry are indexed under Heart Valve Diseases; 172 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 290 interventional studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
This study is terminated, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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University Hospital, Bordeaux