Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

NCT00221663 — Phase 2 / Phase 3, Terminated, 78 participants, University Hospital, Bordeaux

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

Registry	NCT00221663
Status	Terminated - slow recruitment
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: single, diagnostic
Enrollment	78 (Actual)
Sponsor	University Hospital, Bordeaux (Other); collaborators: Ministry of Health, France
Conditions	Heart Valve Diseases
Interventions	surgery techniques (sternotomy for aortic valve replacement) (Device)
Dates	start 2002-01-01, primary completion 2002-01-01, completion 2006-12-01, first posted 2005-09-22, last updated 2008-08-15
Locations	1 site in France

-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.

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+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.

+Arms and interventions

surgery techniques (sternotomy for aortic valve replacement) (Device)

+Outcome measures

Primary outcomes

Forced expiratory volume and peak expiratory volume/second [at 48 hours]

Secondary outcomes

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
Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time
Consumption of analgetics
Morbidity and mortality during hospital stay

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Hôpital Cardiologique du Haut Lévêque	Pessac	France

+Investigators

Gerard Janvier, Pr, Principal investigator, University Hospital, Bordeaux
Joachim Calderon, Dr, Principal investigator, University Hospital, Bordeaux France
Geneviéve Chene, Pr, Study chair, University Hospital, Bordeaux France

My Notes

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