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

Study Overview
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Brief Summary
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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.

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

Conditions
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Foramen Ovale, Patent

Intervention / Treatment
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* Drug: Aspirin
* Device: Cardiovascular Implantable Device (CIED)
* Device: Gore Cardioform Septal Occluder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PFO Closure<br>Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder. | Drug: Aspirin<br>* Subjects will receive 81 mg enteric coated aspirin<br>* Other names: Acetylsalicylic acid (ASA);Device: Cardiovascular Implantable Device (CIED)<br>* All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).<br>Device: Gore Cardioform Septal Occluder<br>* The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).<br>|
| Other: Control<br>Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED) | Drug: Aspirin<br>* Subjects will receive 81 mg enteric coated aspirin<br>* Other names: Acetylsalicylic acid (ASA);Device: Cardiovascular Implantable Device (CIED)<br>* All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Embolic Brain Lesions Detected on MRI >3 mm | The mean number of embolic brain lesions will be calculated at approximately 1 year. | 1 year post implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Die | The mean number of deaths will be calculated at approximately 1 year. | 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. | 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. | 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. | baseline, 1 year post implantation | 
| Change in Language as Measured by Letter and Category Fluency Test | The examiner gives the subject a category and ask them to name all the different examples that they can think of from that category in one minute. Examples of categories are animals, fruit, birds, breeds of dog, tools, etc. Subjects are also asked to provide examples that start with a given letter. To score, the examiner counts the number of unique responses for a category or letter for one minute; categories can be averaged together. The higher the score the better the language fluency, the lower the score, the worse the language fluency. | baseline, 1 year post implantation | 
| Change in Psychomotor Speed as Measured by Trail Making A Test | Trail Making Test A consists of 25 numbered circles distributed over a sheet of paper. The patient should draw lines to connect the numbers in ascending order. The patient 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 29 seconds; > 78 seconds is considered deficient. | baseline, 1 year post implantation |