Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Status:
Withdrawn
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO)
and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as
a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization
therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the
wall separating the right and left sides) of the heart.
The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform
Septal Occluder in people with an endocardial device leads reduces the risk of recurrent
stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.