Conventional Versus Mini-Sternotomy for Aortic Valve Surgery

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00221663

Enrollment

Registered

2005-09-22

Start date

2002-01-31

Completion date

2006-12-31

Last updated

2008-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Keywords

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

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.

Interventions

DEVICEsurgery techniques (sternotomy for aortic valve replacement)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Forced expiratory volume and peak expiratory volume/second	at 48 hours

Secondary

Measure	Time frame
Peak expiratory volume/s at 24 hours	—
Pro-inflammatory cytokines on tracheal aspiration samples	—
Transfusion requirements during the first 24 hours post operative	—
Forced expiratory volume	at 24 hours
Duration of surgery extracorporeal circulation (ECC) and aortic-cross-clamp-time	—
Consumption of analgetics	—
Morbidity and mortality during hospital stay	—
Hemodynamic parameters	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026