clinical trial · NCT03821129
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
W.L.Gore & Associates·N/A·recruiting·n = 636
StrokePFO - Patent Foramen OvalePFO closure with GORE® CARDIOFORM Septal Occluder
brief 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.
started
Jul 25, 2019
primary completion
Oct 1, 2028
completion
Oct 1, 2031
last updated
May 5, 2026
detailed 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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol