Brief summary

A Prospective, multi-center study to evaluate the safety and performance of the Hyperion™ ASD, PDA and VSD Closure Systems.

The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD, PDA and VSD patients.

Primary endpoints

• 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.
• Device success defined as ASD, PDA or VSD closure at 6 months post procedure by a Transthoracic echocardiography or a Transesophageal echocardiography.

CERC Services

• Kick off activities,
• Clinical trial documentation,
• Regulatory submissions,
• Project management,
• eCRF management,
• Monitoring,
• CEC activities,
• SAE reporting activities,
• Statistical activities.

Countries

Algeria, France, Germany managed by CERC.

China managed by another CRO.

Centers number

8 centers managed by CERC.