Summary
The purpose of the GORE CARDIOFORM Septal Occluder (GSO Device) post-approval study is to assess the safety and effectiveness of GSO device as observed in the REDUCE pivotal IDE study, and to evaluate the quality of the operator education and training and transferability of trial experience to a post-market setting.
Description
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting. A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
Principal Investigator
Study Coordinator
Faculty Contact
Kristi Sutphin - kristi.sutphin@vandaliahealth.org