The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.
Study Type
OBSERVATIONAL
Enrollment
200
CHU Frantz-Fanon
Blida, Algeria
RECRUITINGRadjah Clinic
Sétif, Algeria
NOT_YET_RECRUITINGCentre Médico-chirurgical infantile Bou Ismail
Tipasa, Algeria
Success of implantation
Success of implantation without death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion and without any other device or procedure related MAE at 30 days
Time frame: 30 days
Device success
Device success defined as ASD or PDA closure at 6 months post procedure by a Transthoracic echocardiography (TTE) or a Transesophageal echocardiography (TEE).
Time frame: 6 months
Major Adverse Events
* Major Adverse Events at 6 and 12 months defined as composite rate of all death, stroke, any device embolization, puncture site bleeding requiring surgical repair or blood transfusion at discharge and any other device or procedure related MAE. * Components of Major Adverse Events at discharge, 30 days, 6, and 12 months.
Time frame: 30 days, 6 and 12 months
Procedure success
Procedure success defined as successful deployment of the Hyperion™ Closure System in the patient's ASD and PDA, closure (residual shunt \< 3mm) at 6 months.
Time frame: 6 months
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Anzhen Hospital
Beijing, China
NOT_YET_RECRUITINGShanghai Children's Medical Center
Shanghai, China
NOT_YET_RECRUITINGHôpital cardiologique Haut-Leveque (CHU Bordeaux)
Bordeaux, France
NOT_YET_RECRUITINGHôpital Privé Jacques Cartier
Massy, France
RECRUITINGHopital Necker Enfants Malades
Paris, France
RECRUITINGAmerican Memorial Hospital
Reims, France
NOT_YET_RECRUITINGCardioVascular Center Frankfurt
Frankfurt, Germany
RECRUITING