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Trial record 6 of 233 for:    aortic valve replacement

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Maria Cecilia Hospital
Sponsor:
Collaborator:
Ettore Sansavini Health Science Foundation
Information provided by (Responsible Party):
Maria Cecilia Hospital
ClinicalTrials.gov Identifier:
NCT02278666
First received: October 27, 2014
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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 Intervention
Aortic Valve Surgery
Procedure: aortic valve replacement
Device: biological prosthetic valve
Device: Mechanical valve

Study Type: Observational
Study Design: 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

Further study details as provided by Maria Cecilia Hospital:

Primary Outcome Measures:
  • Cardiopulmonary bypass time [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • Total duration of Intensive Care Unit stay [ Time Frame: during hospital stay, usually lasting one to two weeks ] [ Designated as safety issue: Yes ]
  • Blood transfusions [ Time Frame: during hospital stay, usually lasting one to two weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • renal insufficiency [ Time Frame: during hospital stay, usually lasting one to two weeks ] [ Designated as safety issue: Yes ]
    need for haemofiltration

  • Prolonged ventilation [ Time Frame: during hospital stay ] [ Designated as safety issue: Yes ]
    longer than 24 hours

  • Re-exploration for bleeding [ Time Frame: during hospital stay, usually lasting one to two weeks ] [ Designated as safety issue: Yes ]
    need of surgical revision for bleeding

  • sepsis [ Time Frame: during hospital stay, usually lasting one to two weeks ] [ Designated as safety issue: Yes ]
  • Neurological complications [ Time Frame: during hospital stay, usually lasting one to two weeks ] [ Designated as safety issue: Yes ]
    stroke and/or transient ischemic attacks

  • in-hospital mortality [ Time Frame: during hospital stay, usually lasting one to two weeks ] [ Designated as safety issue: Yes ]
  • 30-day mortality [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: October 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02278666

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

Locations
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
  More Information

No publications provided

Responsible Party: Maria Cecilia Hospital
ClinicalTrials.gov Identifier: NCT02278666     History of Changes
Other Study ID Numbers: ESREFO21
Study First Received: October 27, 2014
Last Updated: November 3, 2014
Health Authority: Italy: Ministry of Health

ClinicalTrials.gov processed this record on November 25, 2014