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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03821129
Study type Interventional
Source W.L.Gore & Associates
Contact Tammy DeLozier
Phone 800-437-8181
Email GSO1801@wlgore.com
Status Recruiting
Phase N/A
Start date July 25, 2019
Completion date December 2029

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