Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Phase 2

Terminated

• Conditions: Heart Valve Diseases

• Registration Number: NCT00221663
• Lead Sponsor: University Hospital, Bordeaux

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, 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.

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2002-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Study Completion: 2006-12
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-14
• Last Update Posted: 2008-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Indication of isolated aortic valvular replacement
• Preoperative ASA class < = 3
• Left ventricular ejection fraction > = 40%
• Signed informed consent

Exclusion Criteria

• Aortic or mitral insufficiency > 3
• History of cardiac surgery
• Acute pulmonary edema
• Endocarditis
• Chronic renal insufficiency decompensation
• Operative coagulation disorders regardless of etiology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume and peak expiratory volume/second	at 48 hours

Secondary Outcome Measures

Name	Time	Method
Forced expiratory volume	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

Trial Locations

Locations (1)

Hôpital Cardiologique du Haut Lévêque; 🇫🇷 Pessac, France