Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

University Hospital of Bordeaux

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Heart Valve Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00221663

2000-05

7945-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind