Condition: Sinus Venosus Defect · Congenital Heart Disease · Sinus Venosus Atrial Septum Defect · Sponsor: Centre Chirurgical Marie Lannelongue
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 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 …
This description comes directly from the study's public registry record.
SEBASTIEN HASCOËT · +33140942429 · s.hascoet@ghpsj.fr
FLORENCE LECERF · +33140942517 · f.lecerf@ghpsj.fr
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| 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 |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05865119