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.
- 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.
- Kick off activities,
- Clinical trial documentation,
- Regulatory submissions,
- Project management,
- eCRF management,
- CEC activities,
- SAE reporting activities,
- Statistical activities.
Algeria, France, Germany managed by CERC.
China managed by another CRO.
8 centers managed by CERC.