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OPTImal Treatment of Sinus VENOSUS Defect

RecruitingNAAges 12 Years - anyAllCentre Chirurgical Marie Lannelongue
NCT05865119 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Sinus venosus defect (SVD) accounts for 10% of atrial septal defects and is characterized by an anomalous pulmonary venous return in the superior vena cava associated with a high situated atrial septal defect. Since 2013, transcatheter correction of this congenital heart disease has emerged as a new treatment option. The procedure involves placement of a covered stent in the superior vena cava that tunnels the anomalous pulmonary venous return to the left atrium. Preliminary results are limited but promising. The devices to be used depend on anatomic considerations. XXL stents than 70mm are often required. Today, the availability of CE marked stents is limited. There have been recent reports of successful corrections with the specifically developed Optimus XXL 100mm covered stent (ANDRATEC) with compassionate approval from the Agence Nationale de Sûreté du Médicament in France. Setting

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📋 Eligibility rules (as published)
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
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What it tests

  • OPTIMUS covered stent
  • Surgical correction of a SVD
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Where

13 sites
CHU Bordeaux
Bordeaux, France
Hospices Civils de Lyon
Bron, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
Sébastien HASCOËT
Le Plessis-Robinson, France
CHU Lille
Lille, France
Hôpitaux universitaire de Marseille
Marseille, France
CHU Nantes
Nantes, France

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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