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

Mayo Clinic

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Foramen Ovale, Patent

Interventions

AspirinDRUG

Subjects will receive 81 mg enteric coated aspirin

Cardiovascular Implantable Device (CIED)DEVICE

All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).

Gore Cardioform Septal OccluderDEVICE

The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Number of Embolic Brain Lesions Detected on MRI >3 mm

The mean number of embolic brain lesions will be calculated at approximately 1 year.

Time frame: 1 year post implantation

Secondary Outcomes

Number of Subjects Who Die

The mean number of deaths will be calculated at approximately 1 year.

Time frame: 1 year post implantation

Number of Subjects Who Experience a Stroke

Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

Time frame: 1 year post implantation

Number of Subjects who Experience a Transient Ischemic Attack (TIA)

Transient ischemic attack (TIA) is defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.

Time frame: 1 year post implantation

Change in Executive Function as Measured by Trail Making Test B

Trail Making Test B consists of 25 circles including both numbers (1-13) and letters (A-L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; \> 273 seconds is considered deficient. Trail Making Test B consists of 25 circles including both numbers (1 - 13) and letters (A - L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; \> 273 seconds is considered deficient.

Data from ClinicalTrials.gov

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