Stent through a vein versus open surgery for sinus venosus defect
Compares a covered stent with surgery for sinus venosus defect, a congenital heart condition.
Key facts
- Who runs it
- Centre Chirurgical Marie Lannelongue
- Where
- Bordeaux, Bron, Clermont-Ferrand, Grenoble, Le Plessis-Robinson, Lille, Marseille, Nantes, Paris, Toulouse, and Tours, FranceSee the 13 sites
- Trial code
- Registry title
- OPTImal Treatment of Sinus VENOSUS Defect
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 12 May 2023
- Expected to end
- 12 May 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- OPTIMUS covered stent
- Surgical correction of a SVD
- Record updated
- 14 August 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 or older with a sinus venosus defect, a type of hole between the upper heart chambers, who need it repaired. It compares repair through a tube in a blood vessel (a covered stent) with surgery.
- Age
- 12 years and older. Minor patients (children) can only be in the surgery group.
- Sex
- All sexes
- Disease stage
- Sinus venosus defect with an enlarged right lower heart chamber on imaging (echocardiography and/or MRI). This means RV EDV greater than 112mL/m2 for women and 121 mL/m2 for men. A medical-surgical team must have decided the defect needs repair under the ESC 2020 guideline.
Main reasons for not taking part
- Under guardianship, curatorship or judicial protection
- Deprived of liberty
- Pregnant or breastfeeding
- Already in another interventional research study
- Not covered by a social security plan
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in France
- CHU BordeauxBordeaux, FranceContact: Jean-Benoit THAMBONot yet recruiting
- Hospices Civils de LyonBron, FranceContact: Mohamed BAKLOULNot yet recruiting
- CHU Clermont-FerrandClermont-Ferrand, FranceContact: Claire DAUPHINNot yet recruiting
- Chu GrenobleGrenoble, FranceContact: Hélène BOUVAISTTaking people
- Sébastien HASCOËTLe Plessis-Robinson, FranceContact: Sébastien HASCOËTTaking people
- CHU LilleLille, FranceContact: François GODARTTaking people
- Hôpitaux universitaire de MarseilleMarseille, FranceContact: Caroline OVAERTNot yet recruiting
- CHU NantesNantes, FranceContact: Alban-Elouen BARUTEAUNot yet recruiting
- CHU Necker APHP ParisParis, FranceContact: Sophie MALEKZADEHNot yet recruiting
- HEGP ParisParis, FranceContact: Sophie MALEKZADEHNot yet recruiting
- CHU ToulouseToulouse, FranceContact: Clément KARSENTYNot yet recruiting
- Clinique Pasteur - ToulouseToulouse, FranceContact: Nicolas COMBESNot yet recruiting
- CHU ToursTours, FranceContact: Bruno LEFORTNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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 up a feasibility study to investigate the use of medical devices in this indication was required.
The objective of this project is to study the feasibility, efficacy and safety of the Optimus stent in this newly developed transcatheter procedure, in comparison with the gold-standard surgical method. A French national multicenter comparative cohort study including all eligible patients referred for transcatheter correction of SVD was designed. The feasibility of the transcatheter procedures will be investigated beforehand by virtual digital simulation and simulation on a 3D printed model. The procedures will then be performed in centers of the M3C network for complex congenital heart diseases (CARDIOGEN). The primary endpoint will be a composite of efficacy, defined as complete occlusion of the shunt, and safety, defined as the absence of major events at 6 months. The secondary endpoints will be anatomical, functional and psychosocial (quality of life).
It is expected that transcatheter treatment gives comparable results to surgery on the primary endpoint. This could justify the further development of this procedure as an alternative to surgery and facilitate the validation of dedicated equipment.
The 2 groups in the trial
- endovascularTreatment being tested
Transcatheter correction of a SVD with an OPTIMUS covered stent
Treatment: OPTIMUS covered stent
- surgeryExisting treatment, for comparison
Surgical correction of a SVD
Treatment: Surgical correction of a SVD
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- OPTImal Treatment of Sinus VENOSUS Defect - Efficacy and Safety of Transcatheter Correction Compared to Surgical Treatment in Patients With Sinus Venosus Defect
- Plain-language title
- Stent through a vein versus open surgery for sinus venosus defectGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 14 August 2023