Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry (SATURNO)

Maria Cecilia Hospital

Status: Completed

Conditions: Aortic Valve Surgery

Treatments: Device: Mechanical valve; Procedure: aortic valve replacement; Device: biological prosthetic valve

Study type: Observational

Funder types: Other

Identifiers

NCT02278666

ESREFO21

Details and patient eligibility

About

The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.

Full description

The study will focus on data recorded and collected from daily clinical treatment of patients undergoing isolated aortic valve replacement due to symptomatic aortic stenosis who consented to the use of their personal data. After surgery patients will be followed up to a minimum of 12 months. In-hospital and follow-up outcomes of the different surgical approaches will be analysed.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients undergoing isolated aortic valve surgery
• Written Informed consent to the use of personal data

Exclusion criteria

• other associated cardiac surgery
• emergency surgery

Trial design

1,000 participants in 3 patient groups

upper mini-sternotomy

Description:

aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)

Treatment:

Device: Mechanical valve

Procedure: aortic valve replacement

Device: biological prosthetic valve

right mini thoracotomy

Description:

aortic valve replacement/repair surgery via right mini thoracotomy

Treatment:

Device: Mechanical valve

Procedure: aortic valve replacement

Device: biological prosthetic valve

conventional sternotomy

Description:

aortic valve replacement surgery via conventional full sternotomy

Treatment:

Device: Mechanical valve

Procedure: aortic valve replacement

Device: biological prosthetic valve