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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00221663
• Other study ID #: 7945-00
• Secondary ID: 2000-05
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 13, 2005
• Last updated: August 14, 2008
• Start date: January 2002
• Est. completion date: December 2006

Study information

• Verified date: August 2008
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: December 2006
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Device:
• surgery techniques (sternotomy for aortic valve replacement)

Locations

Country	Name	City	State
France	Hôpital Cardiologique du Haut Lévêque	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced expiratory volume and peak expiratory volume/second		at 48 hours	No
Secondary	Forced expiratory volume		at 24 hours
Secondary	Peak expiratory volume/s at 24 hours
Secondary	Pro-inflammatory cytokines on tracheal aspiration samples
Secondary	Transfusion requirements during the first 24 hours post operative
Secondary	Hemodynamic parameters
Secondary	Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
Secondary	Consumption of analgetics
Secondary	Morbidity and mortality during hospital stay