Aortic Valve SurgerySATURNONCT02278666
Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry
An observational study of Aortic Valve Surgery, run by Maria Cecilia Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Surgery
- What is being tested?
- aortic valve replacement, biological prosthetic valve and Mechanical valve
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing isolated aortic valve surgery
Who may be able to join
- All patients undergoing isolated aortic valve surgery
- Written Informed consent to the use of personal data
Who cannot join
- other associated cardiac surgery
- emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques
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.
Read the 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.
- Conditions
- Aortic Valve Surgery
- Being tested
- aortic valve replacement, biological prosthetic valve, Mechanical valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic valve replacementProcedure or surgery
Also called AVR
aortic valve replacement with either biological prosthetic valve or mechanical valve
biological prosthetic valveDevice
aortic valve replacement with either biological prosthetic valve or mechanical valve
Mechanical valveDevice
aortic valve replacement with either biological prosthetic valve or mechanical valve
| Study group | Role | What they receive |
|---|---|---|
| upper mini-sternotomy | aortic valve replacement surgery via upper J or T sternotomy (ministernotomy) Receives: Procedure: aortic valve replacement; Device: biological prosthetic valve; Device: Mechanical valve | |
| right mini thoracotomy | aortic valve replacement/repair surgery via right mini thoracotomy Receives: Procedure: aortic valve replacement; Device: biological prosthetic valve; Device: Mechanical valve | |
| conventional sternotomy | aortic valve replacement surgery via conventional full sternotomy Receives: Procedure: aortic valve replacement; Device: biological prosthetic valve; Device: Mechanical valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary bypass time
Measured: during surgery
Total duration of Intensive Care Unit stay
Measured: during hospital stay, usually lasting one to two weeks
Blood transfusions
Measured: during hospital stay, usually lasting one to two weeks
Secondary outcomes (7)
renal insufficiency
need for haemofiltration
Measured: during hospital stay, usually lasting one to two weeks
Prolonged ventilation
longer than 24 hours
Measured: during hospital stay
Re-exploration for bleeding
need of surgical revision for bleeding
Measured: during hospital stay, usually lasting one to two weeks
sepsis
Measured: during hospital stay, usually lasting one to two weeks
Neurological complications
stroke and/or transient ischemic attacks
Measured: during hospital stay, usually lasting one to two weeks
in-hospital mortality
Measured: during hospital stay, usually lasting one to two weeks
30-day mortality
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ettore Sansavini Health Science Foundation
- Responsible party
- Sponsor
- Investigators
- Elisa Mikus, MD, Principal investigator, Maria Cecilia Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278666
- Sponsor's protocol ID
- ESREFO21
- Acronym
- SATURNO
- Status last verified
- Jul 2022
- First submitted
- 27 Oct 2014
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques
- ClinicalTrials.gov ID
- NCT02278666
- Acronym / sponsor ID
- SATURNO / ESREFO21
- Conditions
- Aortic Valve Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Collaborators
- Ettore Sansavini Health Science Foundation
- Study start
- Oct 2014 (actual)
- Primary completion
- Nov 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| upper mini-sternotomy | – | Procedure: aortic valve replacement, Device: biological prosthetic valve, Device: Mechanical valveaortic valve replacement surgery via upper J or T sternotomy (ministernotomy) |
| right mini thoracotomy | – | Procedure: aortic valve replacement, Device: biological prosthetic valve, Device: Mechanical valveaortic valve replacement/repair surgery via right mini thoracotomy |
| conventional sternotomy | – | Procedure: aortic valve replacement, Device: biological prosthetic valve, Device: Mechanical valveaortic valve replacement surgery via conventional full sternotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing isolated aortic valve surgery
Key inclusion criteria (2 listed)
- All patients undergoing isolated aortic valve surgery
- Written Informed consent to the use of personal data
Key exclusion criteria (2 listed)
- other associated cardiac surgery
- emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aortic valve replacementAlso: AVRaortic valve replacement with either biological prosthetic valve or mechanical valve | Procedure or surgery | conventional sternotomy, right mini thoracotomy, upper mini-sternotomy |
| biological prosthetic valveaortic valve replacement with either biological prosthetic valve or mechanical valve | Device | conventional sternotomy, right mini thoracotomy, upper mini-sternotomy |
| Mechanical valveaortic valve replacement with either biological prosthetic valve or mechanical valve | Device | conventional sternotomy, right mini thoracotomy, upper mini-sternotomy |
Primary outcome
Cardiopulmonary bypass time
Time frame: during surgery
Total duration of Intensive Care Unit stay
Time frame: during hospital stay, usually lasting one to two weeks
Blood transfusions
Time frame: during hospital stay, usually lasting one to two weeks
7 secondary outcomes
renal insufficiency
Time frame: during hospital stay, usually lasting one to two weeks
Prolonged ventilation
Time frame: during hospital stay
Re-exploration for bleeding
Time frame: during hospital stay, usually lasting one to two weeks
sepsis
Time frame: during hospital stay, usually lasting one to two weeks
Neurological complications
Time frame: during hospital stay, usually lasting one to two weeks
in-hospital mortality
Time frame: during hospital stay, usually lasting one to two weeks
30-day mortality
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa Mikus, MD principal investigator
Maria Cecilia Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Surgery, run by Maria Cecilia Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary bypass time (time frame: during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.