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
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 April 22, 2014