Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Sammy Elmariah, MD

Description

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.

Details

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.

Keywords

Stroke, PFO - Patent Foramen Ovale, Occluder, Patent Foramen Ovale, PFO, Gore Septal Occluder, PFO closure with GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM Septal Occluder

Eligibility

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Santa Barbara Cottage Hospital accepting new patients
    Santa Barbara California 93105 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
W.L.Gore & Associates
ID
NCT03821129
Study Type
Interventional
Participants
Expecting 636 study participants
Last Updated