Status:
WITHDRAWN
Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Lead Sponsor:
Mayo Clinic
Conditions:
Foramen Ovale, Patent
Eligibility:
All Genders
18-85 years
Phase:
NA
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03232450
Start Date
August 1 2019
End Date
December 1 2023
Last Update
March 13 2020
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905