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Studies

Interventional Recruiting

NCT05865119 on ClinicalTrials.gov

OPTImal Treatment of Sinus VENOSUS Defect

Official title: OPTImal Treatment of Sinus VENOSUS Defect - Efficacy and Safety of Transcatheter Correction Compared to Surgical Treatment in Patients With Sinus Venosus Defect

  • Sponsor: Centre Chirurgical Marie Lannelongue
  • Enrollment: 60 (Estimated)
  • Study start: 2023-05-12 (Actual)
  • Primary completion: 2024-05-12 (Estimated)
  • Study completion: 2029-05-12 (Estimated)
  • Allocation: Non-Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

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 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.

Conditions

  • Sinus Venosus Defect
  • Congenital Heart Disease
  • Sinus Venosus Atrial Septum Defect

Intervention / Treatment

  • Device: OPTIMUS covered stent
  • Procedure: Surgical correction of a SVD

Primary Outcome Measures

  • Number of participants meeting the primary net criteria in the 2 groups (At six month)
    Number of participants (%) with complete occlusion of the shunt AND absence of a major procedure-related event (death or open-heart surgery).

Countries

France

Locations and Investigators

  • CHU Bordeaux, Bordeaux, France (Not yet recruiting)
  • Hospices Civils de Lyon, Bron, France (Not yet recruiting)
    • Mohamed BAKLOUL
    • Mohamed BAKLOUL (Principal Investigator)
  • CHU Clermont-Ferrand, Clermont-Ferrand, France (Not yet recruiting)
    • Claire DAUPHIN
    • Claire DAUPHIN (Principal Investigator)
  • CHU Grenoble, Grenoble, France (Recruiting)
    • Hélène BOUVAIST
    • Helene BOUVAIST (Principal Investigator)
  • Sébastien HASCOËT, Le Plessis-Robinson, France (Recruiting)
  • CHU Lille, Lille, France (Recruiting)
    • François GODART
    • François GODART (Principal Investigator)
  • Hôpitaux universitaire de Marseille, Marseille, France (Not yet recruiting)
    • Caroline OVAERT
    • Caroline OVAERT (Principal Investigator)
  • CHU Nantes, Nantes, France (Not yet recruiting)
  • CHU Necker APHP Paris, Paris, France (Not yet recruiting)
    • Sophie MALEKZADEH
    • Sophie MALEKZADEH (Principal Investigator)
  • HEGP Paris, Paris, France (Not yet recruiting)
    • Sophie MALEKZADEH
    • Sophie MALEKZADEH (Principal Investigator)
  • CHU Toulouse, Toulouse, France (Not yet recruiting)
    • Clément KARSENTY
    • Clément KARSENTY (Principal Investigator)
  • Clinique Pasteur, Toulouse, Toulouse, France (Not yet recruiting)
  • CHU Tours, Tours, France (Not yet recruiting)
    • Bruno LEFORT
    • Bruno LEFORT (Principal Investigator)

Study Officials