Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
- Conditions
- Foramen Ovale, Patent
- Interventions
- Device: Cardiovascular Implantable Device (CIED)Device: Gore Cardioform Septal Occluder
- Registration Number
- NCT03232450
- Lead Sponsor
- Mayo Clinic
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PFO Closure Aspirin Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder. Control Cardiovascular Implantable Device (CIED) Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED) PFO Closure Gore Cardioform Septal Occluder Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder. Control Aspirin Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED) PFO Closure Cardiovascular Implantable Device (CIED) Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.
- Primary Outcome Measures
Name Time Method Number of Embolic Brain Lesions Detected on MRI >3 mm 1 year post implantation The mean number of embolic brain lesions will be calculated at approximately 1 year.
- Secondary Outcome Measures
Name Time Method Number of Subjects Who Die 1 year post implantation The mean number of deaths will be calculated at approximately 1 year.
Number of Subjects who Experience a Transient Ischemic Attack (TIA) 1 year post implantation 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.
Change in Language as Measured by Letter and Category Fluency Test baseline, 1 year post implantation 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.
Number of Subjects Who Experience a Stroke 1 year post implantation 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.
Change in Psychomotor Speed as Measured by Trail Making A Test baseline, 1 year post implantation 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.
Change in Executive Function as Measured by Trail Making Test B baseline, 1 year post implantation 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.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States