This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

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

Condition Intervention Phase
Heart Valve Diseases Device: surgery techniques (sternotomy for aortic valve replacement) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults

Resource links provided by NLM:

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Forced expiratory volume and peak expiratory volume/second [ Time Frame: at 48 hours ]

Secondary Outcome Measures:
  • 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

Enrollment: 78
Study Start Date: January 2002
Study Completion Date: December 2006
Primary Completion Date: January 2002 (Final data collection date for primary outcome measure)
Detailed Description:


Minimally invasive techniques for cardiac surgery should be formally evaluated.


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00221663

Hôpital Cardiologique du Haut Lévêque
Pessac, France, 33604
Sponsors and Collaborators
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
  More Information

Responsible Party: Jean Pierre LEROY, University Hospital, Bordeaux Identifier: NCT00221663     History of Changes
Other Study ID Numbers: 7945-00
Study First Received: September 13, 2005
Last Updated: August 14, 2008

Keywords provided by University Hospital, Bordeaux:
Cardiac surgery
Aortic valve replacement
Minimally invasive surgery
Perioperative course

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases processed this record on August 17, 2017