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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jean Pierre LEROY, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00221663     History of Changes
Other Study ID Numbers: 7945-00, 2000-05
Study First Received: September 13, 2005
Last Updated: August 14, 2008
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 31, 2014