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Completed

NCT Number: NCT02278666

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

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.

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Key information

Conditions

Aortic Valve Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Cecilia Hospital

Cotignola, Ravenna, 48010, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic valve replacement

Procedure

aortic valve replacement with either biological prosthetic valve or mechanical valve

Other names: AVR

biological prosthetic valve

Device

aortic valve replacement with either biological prosthetic valve or mechanical valve

Mechanical valve

Device

aortic valve replacement with either biological prosthetic valve or mechanical valve

Primary outcomes

  1. Cardiopulmonary bypass time

    Time frame: during surgery

  2. Total duration of Intensive Care Unit stay

    Time frame: during hospital stay, usually lasting one to two weeks

  3. Blood transfusions

    Time frame: during hospital stay, usually lasting one to two weeks

Secondary outcomes

  1. renal insufficiency

    Time frame: during hospital stay, usually lasting one to two weeks

    need for haemofiltration

  2. Prolonged ventilation

    Time frame: during hospital stay

    longer than 24 hours

  3. Re-exploration for bleeding

    Time frame: during hospital stay, usually lasting one to two weeks

    need of surgical revision for bleeding

  4. sepsis

    Time frame: during hospital stay, usually lasting one to two weeks

  5. Neurological complications

    Time frame: during hospital stay, usually lasting one to two weeks

    stroke and/or transient ischemic attacks

  6. in-hospital mortality

    Time frame: during hospital stay, usually lasting one to two weeks

  7. 30-day mortality

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

Maria Cecilia Hospital

Other

Collaborators

  • Ettore Sansavini Health Science Foundation

Registry information

Official study title

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

Acronym: SATURNO

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2014
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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