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

Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02278666
Acronym
SATURNO
Enrollment
1000
Registered
2014-10-30
Start date
2014-10-31
Completion date
2022-12-31
Last updated
2023-09-13

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

Conditions

Aortic Valve Surgery

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREaortic valve replacement

aortic valve replacement with either biological prosthetic valve or mechanical valve

DEVICEbiological prosthetic valve

aortic valve replacement with either biological prosthetic valve or mechanical valve

DEVICEMechanical valve

aortic valve replacement with either biological prosthetic valve or mechanical valve

Sponsors

Ettore Sansavini Health Science Foundation
CollaboratorOTHER
Maria Cecilia Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Cardiopulmonary bypass timeduring surgery
Total duration of Intensive Care Unit stayduring hospital stay, usually lasting one to two weeks
Blood transfusionsduring hospital stay, usually lasting one to two weeks

Secondary

MeasureTime frameDescription
Re-exploration for bleedingduring hospital stay, usually lasting one to two weeksneed of surgical revision for bleeding
sepsisduring hospital stay, usually lasting one to two weeks
30-day mortality30 days after surgery
in-hospital mortalityduring hospital stay, usually lasting one to two weeks
Neurological complicationsduring hospital stay, usually lasting one to two weeksstroke and/or transient ischemic attacks
renal insufficiencyduring hospital stay, usually lasting one to two weeksneed for haemofiltration
Prolonged ventilationduring hospital staylonger than 24 hours

Countries

Italy

Outcome results

None listed

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