Hyperion

HYPERION

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.

Center number:

8 centers managed by CERC.

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