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Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation — PFOCUS  

Foramen Ovale, Patent Clinical Trial

Official title:
PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03232450
Study type Interventional
Source Mayo Clinic
Contact
Status Withdrawn
Phase N/A
Start date August 2019
Completion date December 2023
View Details
See also
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