Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

This study has been terminated.
(slow recruitment)
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221663
First received: September 13, 2005
Last updated: August 14, 2008
Last verified: August 2008

September 13, 2005
August 14, 2008
January 2002
January 2002   (final data collection date for primary outcome measure)
Forced expiratory volume and peak expiratory volume/second [ Time Frame: at 48 hours ] [ Designated as safety issue: No ]
Forced expiratory volume and peak expiratory volume/second at 48 hours
Complete list of historical versions of study NCT00221663 on ClinicalTrials.gov Archive Site
  • 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
  • - 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 ECC and aortic-cross-clamp-time
  • - Consumption of analgetics
  • - Morbidity and mortality during hospital stay
Not Provided
Not Provided
 
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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Heart Valve Diseases
Device: surgery techniques (sternotomy for aortic valve replacement)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
78
December 2006
January 2002   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00221663
7945-00, 2000-05
Yes
Jean Pierre LEROY, University Hospital, Bordeaux
University Hospital, Bordeaux
Ministry of Health, France
Principal Investigator: Gerard Janvier, Pr University Hospital, Bordeaux
Principal Investigator: Joachim Calderon, Dr University Hospital, Bordeaux France
Study Chair: Geneviéve Chene, Pr University Hospital, Bordeaux France
University Hospital, Bordeaux
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP