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Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

NCT ID: NCT00221663

Last Updated: 2008-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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Heart Valve Diseases

Keywords

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Cardiac surgery Aortic valve replacement Minimally invasive surgery Perioperative course

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Interventions

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surgery techniques (sternotomy for aortic valve replacement)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Bordeaux

Principal Investigators

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Gerard Janvier, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Joachim Calderon, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux France

Geneviéve Chene, Pr

Role: STUDY_CHAIR

University Hospital, Bordeaux France

Locations

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Hôpital Cardiologique du Haut Lévêque

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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2000-05

Identifier Type: -

Identifier Source: secondary_id

7945-00

Identifier Type: -

Identifier Source: org_study_id