OPTImal Treatment of Sinus VENOSUS Defect (OPTIVENOSUS)
Sinus Venosus Defect, Congenital Heart Disease, Sinus Venosus Atrial Septum Defect
About this trial
This is an interventional treatment trial for Sinus Venosus Defect focused on measuring congenital heart disease, sinus venosus, stent, surgery, comparative study, 3D printing, simulation, rare disease, optimus, catheterization
Eligibility Criteria
Inclusion Criteria: from 12 years of age SVD with right ventricular end-diastolic volume dilatation (RV EDV) on imaging (echocardiography and/or MRI), defined by the guidelines as RV EDV greater than 112mL/m2 for women and 121 mL/m2 for men. With an indication for atrial septal defect correction, indicated at a medical-surgical meeting according to the ESC 2020 guideline criteria Adult patients who received informed information about the study and signed a consent to participate in the study Minor patients, no opposition from both holders of parental authority to data processing. Patient agreeing to be followed for the duration of the study Affiliated or beneficiary of a social security plan NB: Minor patients will only be considered eligible for the surgical procedure and will be studied descriptively. Exclusion Criteria: Patient under guardianship or curatorship Patient deprived of liberty Patient under judicial protection Pregnant or breastfeeding woman Patient already included in an interventional research protocol
Sites / Locations
- CHU Bordeaux
- Hospices Civils de Lyon
- CHU Clermont-Ferrand
- CHU GrenobleRecruiting
- Sébastien HASCOËTRecruiting
- CHU LilleRecruiting
- Hôpitaux universitaire de Marseille
- CHU Nantes
- CHU Necker APHP Paris
- HEGP Paris
- CHU Toulouse
- Clinique Pasteur, Toulouse
- CHU Tours
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
endovascular
surgery
Transcatheter correction of a SVD with an OPTIMUS covered stent
Surgical correction of a SVD