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Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

This study has been terminated.
(slow recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00221663
First Posted: September 22, 2005
Last Update Posted: August 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
  Purpose
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:

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.

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221663


Locations
France
Hôpital Cardiologique du Haut Lévêque
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
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
ClinicalTrials.gov Identifier: NCT00221663     History of Changes
Other Study ID Numbers: 7945-00
2000-05
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: August 15, 2008
Last Verified: August 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