NCT00221663

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 15, 2008

Status Verified

August 1, 2008

Enrollment Period

Same day

First QC Date

September 13, 2005

Last Update Submit

August 14, 2008

Conditions

Heart Valve Diseases

Keywords

Cardiac surgeryAortic valve replacementMinimally invasive surgeryPerioperative course

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume and peak expiratory volume/second

    at 48 hours

Secondary Outcomes (8)

  • Forced expiratory volume

    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

  • +3 more secondary outcomes

Interventions

surgery techniques (sternotomy for aortic valve replacement)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication of isolated aortic valvular replacement
  • Preoperative ASA class \< = 3
  • Left ventricular ejection fraction \> = 40%
  • Signed informed consent

You may not qualify if:

  • Aortic or mitral insufficiency \> 3
  • History of cardiac surgery
  • Acute pulmonary edema
  • Endocarditis
  • Chronic renal insufficiency decompensation
  • Operative coagulation disorders regardless of etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cardiologique du Haut Lévêque

Pessac, 33604, France

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Sternotomy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Gerard Janvier, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Joachim Calderon, Dr

    University Hospital, Bordeaux France

    PRINCIPAL INVESTIGATOR

  • Geneviéve Chene, Pr

    University Hospital, Bordeaux France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

January 1, 2002

Primary Completion

January 1, 2002

Study Completion

December 1, 2006

Last Updated

August 15, 2008

Record last verified: 2008-08

Locations

FR(1)