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.
ClinicalTrials.gov ID: NCT02220270
Study objectives
COMED
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
- Full Services
Countries
Algeria, France, Germany managed by CERC.
China managed by another CRO.
Number of investigational sites
8/ 10 managed by CERC
Number of patients
200
