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

Aortic Valve Surgery Clinical Trial

— SATURNO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278666
• Other study ID #: ESREFO21
• Status: Completed
• Start date: October 2014
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Maria Cecilia Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Surgery

Intervention

Procedure:
• aortic valve replacement
aortic valve replacement with either biological prosthetic valve or mechanical valve

Device:
• biological prosthetic valve
aortic valve replacement with either biological prosthetic valve or mechanical valve
• Mechanical valve
aortic valve replacement with either biological prosthetic valve or mechanical valve

Locations

Country	Name	City	State
Italy	Maria Cecilia Hospital	Cotignola	Ravenna

Sponsors (2)

Lead Sponsor	Collaborator
Maria Cecilia Hospital	Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary bypass time		during surgery
Primary	Total duration of Intensive Care Unit stay		during hospital stay, usually lasting one to two weeks
Primary	Blood transfusions		during hospital stay, usually lasting one to two weeks
Secondary	renal insufficiency	need for haemofiltration	during hospital stay, usually lasting one to two weeks
Secondary	Prolonged ventilation	longer than 24 hours	during hospital stay
Secondary	Re-exploration for bleeding	need of surgical revision for bleeding	during hospital stay, usually lasting one to two weeks
Secondary	sepsis		during hospital stay, usually lasting one to two weeks
Secondary	Neurological complications	stroke and/or transient ischemic attacks	during hospital stay, usually lasting one to two weeks
Secondary	in-hospital mortality		during hospital stay, usually lasting one to two weeks
Secondary	30-day mortality		30 days after surgery