Status:
COMPLETED
Investigation of Patients With BAV Requiring Valve and/or Aortic Repair (GISSI Outliers VAR)
Lead Sponsor:
Gruppo di Ricerca GISSI
Conditions:
Bicuspid Aortic Valve
Aortic Regurgitation
Eligibility:
All Genders
18+ years
Brief Summary
Prospective longitudinal study on four small groups of surgical patients affected by: BAV with isolated regurgitation, BAV associated with aorta dilatation, or both and BAV with isolated stenosis in o...
Detailed Description
The aim of the study is to select homogeneous small groups of surgical patients with the same subtype of BAV and same aortic behaviour and identify markers/predictors of favorable-unfavorable aortic w...
Eligibility Criteria
Inclusion
- Men and women over 18 years-old and under the age of 60 (age selection will prevent from enrolling patient with age-related valve and aortic wall degeneration). For the BAV stenosis group there will be considered patients over 60 years-old: including the most frequent form of BAV disease and the commonest age, this group could be used as a control group compared to the outlier ones.
- Echo diagnosis of BAV and indication to surgery:
- BAV with isolated regurgitation, BAV with normal valvular function but associated aorta dilatation, BAV with both valve regurgitation and aortic dilatation BAV with isolated stenosis
- \- Signed informed consent
Exclusion
- Patient with a previous cardiac or great vessels surgery
- coexistent coarctation of the aorta
- non-associated cardiac diseases: valve disease (other than aortic), ischemic disease, congenital heart disease.
- Marfan syndrome or other connective tissue disorders involving aortic valve and aortic wall disease (history of disease or clinical signs).
- Other conditions/circumstances likely to lead to poor study adherence (e.g. psychological or organizational reasons).
- Serious disease other than aortic, severely limiting life expectancy.
- Patients who refuse to give informed consent
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02283970
Start Date
December 1 2012
End Date
July 1 2017
Last Update
August 9 2018
Active Locations (10)
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1
Casa Di Cura Villa Sant'Anna
Catanzaro, CZ, Italy, 88100
2
Aou Careggi
Florence, FI, Italy, 50139
3
Ospedale San Raffaele
Milan, MI, Italy, 20132
4
Centro Cardiologico Monzino
Milan, MI, Italy, 20138