Clinical trial NCT03232450: Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Official title: PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Foramen Ovale, Patent
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Embolic Brain Lesions Detected on MRI >3 mm
timeFrame: 1 year post implantation
Secondary outcomes:
measure: Number of Subjects Who Die
timeFrame: 1 year post implantation
measure: Number of Subjects Who Experience a Stroke
timeFrame: 1 year post implantation
measure: Number of Subjects who Experience a Transient Ischemic Attack (TIA)
timeFrame: 1 year post implantation
measure: Change in Executive Function as Measured by Trail Making Test B
timeFrame: baseline, 1 year post implantation
measure: Change in Language as Measured by Letter and Category Fluency Test
timeFrame: baseline, 1 year post implantation
measure: Change in Psychomotor Speed as Measured by Trail Making A Test
timeFrame: baseline, 1 year post implantation
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Samuel J Asirvatham
role: PRINCIPAL_INVESTIGATOR
References: