NCT00221663

Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, faster recovery, and a shorter hospital stay. However, these advantages have rarely been documented in the setting of a formal randomized controlled trial.

Detailed description

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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	surgery techniques (sternotomy for aortic valve replacement)

Timeline

• Start date: 2002-01-01
• Primary completion: 2002-01-01
• Completion: 2006-12-01
• First posted: 2005-09-22
• Last updated: 2008-08-15

Locations

1 site across 1 country: France