NCT03232450

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Foramen Ovale, Patent

Interventions

Type	Name	Description
DRUG	Aspirin	Subjects will receive 81 mg enteric coated aspirin
DEVICE	Cardiovascular Implantable Device (CIED)	All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
DEVICE	Gore Cardioform Septal Occluder	The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).

Timeline

• Start date: 2019-08-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2017-07-28
• Last updated: 2020-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study