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Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Primary Purpose

Heart Valve Diseases

Status

Terminated

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

surgery techniques (sternotomy for aortic valve replacement)

About this trial

This is an interventional diagnostic trial for Heart Valve Diseases focused on measuring Cardiac surgery, Aortic valve replacement, Minimally invasive surgery, Perioperative course

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Cardiologique du Haut Lévêque

Outcomes

Primary Outcome Measures

Forced expiratory volume and peak expiratory volume/second

Secondary Outcome Measures

Forced expiratory volume

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

Full Information

NCT ID

NCT00221663

First Posted

September 13, 2005

Last Updated

August 14, 2008

Sponsor

University Hospital, Bordeaux

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT00221663

Brief Title

Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

Official Title

Clinical Trial Comparing a Conventional Median Sternotomy Versus a Minimally Invasive Technique for Aortic Valvular Replacement in Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Terminated

Why Stopped

slow recruitment

Study Start Date

January 2002 (undefined)

Primary Completion Date

January 2002 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Bordeaux

Collaborators

Ministry of Health, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Valve Diseases

Keywords

Cardiac surgery, Aortic valve replacement, Minimally invasive surgery, Perioperative course

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

surgery techniques (sternotomy for aortic valve replacement)

Primary Outcome Measure Information:

Title

Forced expiratory volume and peak expiratory volume/second

Time Frame

at 48 hours

Secondary Outcome Measure Information:

Title

Forced expiratory volume

Time Frame

at 24 hours

Title

Peak expiratory volume/s at 24 hours

Title

Pro-inflammatory cytokines on tracheal aspiration samples

Title

Transfusion requirements during the first 24 hours post operative

Title

Hemodynamic parameters

Title

Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time

Title

Consumption of analgetics

Title

Morbidity and mortality during hospital stay

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerard Janvier, Pr

Organizational Affiliation

University Hospital, Bordeaux

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joachim Calderon, Dr

Organizational Affiliation

University Hospital, Bordeaux France

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Geneviéve Chene, Pr

Organizational Affiliation

University Hospital, Bordeaux France

Official's Role

Study Chair

Facility Information:

Facility Name

Hôpital Cardiologique du Haut Lévêque

City

Pessac

ZIP/Postal Code

33604

Country

France

12. IPD Sharing Statement

Learn more about this trial

Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

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