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

Mayo Clinic

Status: Withdrawn

Conditions: Foramen Ovale, Patent

Treatments: Device: Gore Cardioform Septal Occluder; Device: Cardiovascular Implantable Device (CIED); Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03232450

14-005348

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical indication for a transvenous pacemaker or defibrillator implantation,
• Must have a documented PFO determined from Transthoracic Echocardiogram (TTE) echocardiographic agitated saline contrast study that is determined to be feasible for transcatheter closure.
• The GORE® CARDIOFORM Septal Occluder should only be used in subjects whose vasculature is adequate to accommodate a 10 Fr delivery sheath (or 12 Fr delivery sheath when a guidewire is used).
• All subjects must be able to undergo standardized neurocognitive testing, and dementia/mental status examination screening.

Exclusion criteria

• Subjects with a survival expectancy of less than one year.
• Subjects with an atrial septal defect or shunt that clinically requires closure for hemodynamic or other purposes.
• Absence of a clinical indication for a transvenous CIED system.
• Subjects with any clinical indication mandating anticoagulation.
• Subjects with previously placed CIED devices will be excluded.
• Unable to take anti-platelet medications such as aspirin or clopidogrel (Plavix).
• With anatomy where the GORE® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins.
• With active endocarditis, or other infections producing bacteremia, or with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement.
• With known intracardiac thrombi.
• Known pregnancy at the time of automated implantable cardioverter-defibrillator (AICD) implant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

PFO Closure

Active Comparator group

Description:

Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.

Treatment:

Drug: Aspirin

Device: Cardiovascular Implantable Device (CIED)

Device: Gore Cardioform Septal Occluder

Control

Other group

Description:

Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)

Treatment:

Drug: Aspirin

Device: Cardiovascular Implantable Device (CIED)