Treatment for Sinus Venosus Defect
OPTImal Treatment of Sinus VENOSUS Defect - Efficacy and Safety of Transcatheter Correction Compared to Surgical Treatment in Patients With Sinus Venosus Defect
This study is testing a new less invasive stent treatment for people with a heart condition called sinus venosus defect who can't have traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Centre Chirurgical Marie Lannelongue Academic / other |
| Locations | 13 sites (Bordeaux and 12 other locations) |
| Trial ID | NCT05865119 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 12 and older with a diagnosis of sinus venosus defect and specific anatomical criteria.
Not a fit: Patients who are ineligible for surgery due to severe comorbidities or those with certain anatomical considerations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a safer and less invasive treatment option for patients with sinus venosus defect.
How similar studies have performed: Preliminary results from similar studies using transcatheter techniques for congenital heart defects have shown promise, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 12 other locations
- 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)
- CHU Grenoble — Grenoble, France (Recruiting)
- Sébastien HASCOËT — Le Plessis-Robinson, France (Recruiting)
- CHU Lille — Lille, France (Recruiting)
- Hôpitaux universitaire de Marseille — Marseille, France (Not_yet_recruiting)
- CHU Nantes — Nantes, France (Not_yet_recruiting)
- CHU Necker APHP Paris — Paris, France (Not_yet_recruiting)
- HEGP Paris — Paris, France (Not_yet_recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
- Clinique Pasteur, Toulouse — Toulouse, France (Not_yet_recruiting)
- CHU Tours — Tours, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Sebastien HASCOËT — Hôpital Marie Lannelongue
- Study coordinator: Sebastien Hascoët
- Email: s.hascoet@ghpsj.fr
- Phone: +33140942429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.