Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT03232450
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03232450
Study Brief:
Protocol Section:
NCT03232450