Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Heart Valve Diseases Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heart Valve Diseases

• NCT number: NCT00221663
• Study type: Interventional
• Source: University Hospital, Bordeaux
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 2002
• Completion date: December 2006