PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Number of Embolic Brain Lesions Detected on MRI >3 mm
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
PFO Closure
Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.
干预措施: Aspirin (Drug)
PFO Closure
Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.
干预措施: Cardiovascular Implantable Device (CIED) (Device)
PFO Closure
Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.
干预措施: Gore Cardioform Septal Occluder (Device)
Control
Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)
干预措施: Aspirin (Drug)
Control
Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)
干预措施: Cardiovascular Implantable Device (CIED) (Device)
结局指标
主要结局
Number of Embolic Brain Lesions Detected on MRI >3 mm
时间窗: 1 year post implantation
The mean number of embolic brain lesions will be calculated at approximately 1 year.
次要结局
- Number of Subjects Who Die(1 year post implantation)
- Number of Subjects who Experience a Transient Ischemic Attack (TIA)(1 year post implantation)
- Change in Language as Measured by Letter and Category Fluency Test(baseline, 1 year post implantation)
- Number of Subjects Who Experience a Stroke(1 year post implantation)
- Change in Psychomotor Speed as Measured by Trail Making A Test(baseline, 1 year post implantation)
- Change in Executive Function as Measured by Trail Making Test B(baseline, 1 year post implantation)
研究者
Samuel J. Asirvatham
Principal Investigator
Mayo Clinic