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Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

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ClinicalTrials.gov Identifier: NCT00221663
Recruitment Status : Terminated (slow recruitment)
First Posted : September 22, 2005
Last Update Posted : August 15, 2008
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
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.

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
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
Study Start Date : January 2002
Actual Primary Completion Date : January 2002
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Forced expiratory volume [ Time Frame: at 24 hours ]
  2. Peak expiratory volume/s at 24 hours
  3. Pro-inflammatory cytokines on tracheal aspiration samples
  4. Transfusion requirements during the first 24 hours post operative
  5. Hemodynamic parameters
  6. Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
  7. Consumption of analgetics
  8. Morbidity and mortality during hospital stay


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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

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

Responsible Party: Jean Pierre LEROY, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00221663     History of Changes
Other Study ID Numbers: 7945-00
2000-05
First Posted: September 22, 2005    Key Record Dates
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