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

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ClinicalTrials.gov Identifier: NCT02278666
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Ettore Sansavini Health Science Foundation
Information provided by (Responsible Party):
Maria Cecilia Hospital

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.

Condition or disease Intervention/treatment
Aortic Valve Surgery Procedure: aortic valve replacement Device: biological prosthetic valve Device: Mechanical valve

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques
Actual Study Start Date : October 2014
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
upper mini-sternotomy
aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)
Procedure: aortic valve replacement
aortic valve replacement with either biological prosthetic valve or mechanical valve
Other Name: AVR

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

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

right mini thoracotomy
aortic valve replacement/repair surgery via right mini thoracotomy
Procedure: aortic valve replacement
aortic valve replacement with either biological prosthetic valve or mechanical valve
Other Name: AVR

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

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

conventional sternotomy
aortic valve replacement surgery via conventional full sternotomy
Procedure: aortic valve replacement
aortic valve replacement with either biological prosthetic valve or mechanical valve
Other Name: AVR

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients undergoing isolated aortic valve surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278666


Contacts
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Contact: Elisa Mikus, MD elisamikus@yahoo.it
Contact: Luca Dozza, PhD 390545217175 ldozza@esrefo.org

Locations
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Italy
Maria Cecilia Hospital Recruiting
Cotignola, Ravenna, Italy, 48010
Contact: Elisa Mikus, MD         
Principal Investigator: Mauro Del Giglio, MD         
Sponsors and Collaborators
Maria Cecilia Hospital
Ettore Sansavini Health Science Foundation

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Responsible Party: Maria Cecilia Hospital
ClinicalTrials.gov Identifier: NCT02278666    
Other Study ID Numbers: ESREFO21
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018