OPTImal Treatment of Sinus VENOSUS Defect

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 12, 2023

Primary Completion Date

May 12, 2024

Study Completion Date

May 12, 2029

Conditions
Sinus Venosus DefectCongenital Heart DiseaseSinus Venosus Atrial Septum Defect
Interventions
DEVICE

OPTIMUS covered stent

The procedure involves placement of a long and large balloon-expandable covered stent in the superior vena cava that tunnels the abnormal pulmonary venous return to the left atrium.

PROCEDURE

Surgical correction of a SVD

Under cardiopulmonary bypass and open heart surgery, surgical correction of SVD either using single patch, double patch or Warden techniques

Trial Locations (13)

13385

NOT_YET_RECRUITING

Hôpitaux universitaire de Marseille, Marseille

31300

NOT_YET_RECRUITING

CHU Toulouse, Toulouse

NOT_YET_RECRUITING

Clinique Pasteur, Toulouse, Toulouse

33404

NOT_YET_RECRUITING

CHU Bordeaux, Bordeaux

37000

NOT_YET_RECRUITING

CHU Tours, Tours

38700

RECRUITING

CHU Grenoble, Grenoble

44000

NOT_YET_RECRUITING

CHU Nantes, Nantes

59000

RECRUITING

CHU Lille, Lille

63000

NOT_YET_RECRUITING

CHU Clermont-Ferrand, Clermont-Ferrand

69500

NOT_YET_RECRUITING

Hospices Civils de Lyon, Bron

75015

NOT_YET_RECRUITING

CHU Necker APHP Paris, Paris

NOT_YET_RECRUITING

HEGP Paris, Paris

92350

RECRUITING

Sébastien HASCOËT, Le Plessis-Robinson

All Listed Sponsors
lead

Centre Chirurgical Marie Lannelongue

OTHER