Treatment for Sinus Venosus Defect

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of the OPTIMUS covered stent for the transcatheter correction of sinus venosus defect (SVD), a type of congenital heart disease. Patients will undergo a thorough pre-therapeutic assessment including imaging and functional tests to determine their eligibility for the procedure. A multidisciplinary team will evaluate the patient's condition and decide on the feasibility of the endovascular treatment based on clinical assessments and imaging results. The study aims to provide a less invasive treatment option for patients who are ineligible for traditional surgical correction.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Grenoble
  Grenoble, France Recruiting
• Sébastien HASCOËT
  Le Plessis-Robinson, France Recruiting
• CHU Lille
  Lille, France Recruiting
• CHU Bordeaux
  Bordeaux, France Not yet recruiting
• Hospices Civils de Lyon
  Bron, France Not yet recruiting
• CHU Clermont-Ferrand
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Principal investigator: Sebastien HASCOËT — Hôpital Marie Lannelongue
• Study coordinator: Sebastien Hascoët
• Email: s.hascoet@ghpsj.fr
• Phone: +33140942429

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.