Current Studies
Neurology
IRB Number
|
# 2003-226
|
| Description |
The purpose of this study is to
compare the recurrence rate of stroke in patients who had had a cryptogenic
stroke within the last 180 days and have a patent foramen ovale (PFO).
Eligible patients will be assigned to either anticoagulation/antiplatelet
medication (blood thinners) or implantation of the AMPLATZER PFO Occluder
device to close their PFO. If assigned to the device group the device will
be placed in the heart through a large vein using fluoroscopic (X-ray) and
transeosphageal echocardiography guidance. Patients will be sedated for the
procedure and some patients may require general anesthesia. There will be
follow-up appointments at pre-discharge (device pts only), 1, 6, 12, 18, 24
months and annually until trial completion. Repeat transeosphageal
echocardiography will be done every 6 months in those receiving a device
until closure of the PFO is documented. |
| Eligibility Criteria |
Adults ages 18- 60 with a cryptogenic stroke within the last 6 months and
patent foramen ovale. Major exclusions include other likely causes of
stroke, pregnancy, active infections, organ failure, limited life
expectancy, progressive neurological dysfunction, contraindication to
study medications, inability to provide consent or return for follow-up,
and anatomic abnormalities limiting placement of AMPLATZER PFO Occluder |
| Compensation |
No financial compensation is
provided |
| Study Location |
Penn State Milton S. Hershey
Medical Center |
| Investigator Information |
Raymond Reichwein
Department of Neurology |
| To obtain more information about this study please contact: |
Kim Hitz, RN
717-531-3779 |
|
