Closure of Patent Foramen Ovale with the AMPLATZER PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy. IDE #G060145
Study Description
Cerebral strokes occur in approximately 700,000 patients per year in the USA. In determining the cause of stroke in approximately 40% of patients, the cause remains undefined. With the advent of transesophageal echocardiography a number of studies have demonstrated an extremely high incidence of patent foramen ovale (PFOs) in patients with cryptogenic stroke.
The risk of recurrence in cryptogenic patients with PFO's has been reported to be extremely high. In the study of Bridges et al, 50% of patients had a history of recurrent strokes prior to device closure with the "Clamshell double umbrella" device. Following closure, recurrences were not seen due to paradoxical embolism. This was the most persuasive study to demonstrate the risk of recurrent strokes in these patients and the role that device closure may play in preventing recurrent strokes.
Feasibility of percutaneous PFO closure in patients with paradoxical embolism has been documented in previous studies using a variety of devices. Although this procedure has been successful in >95% of patients, safety concerns have been raised due to periprocedural complication like device embolization, thrombus formation, air embolism, and puncture site problems.
The risks of medical treatment relate to adverse events of antithrombotic therapy. Bleeding is the main complication of oral anticoagulant therapy with Coumadin and is influenced by the intensity of anticoagulation and the concomitant use of antiplatelet agents. The bleeding risk appears higher in patients with a history of prior stroke or gastrointestinal bleeding. Intracranial hemorrhage is estimated to occur with an incidence of 0.5% per year in patients on oral anticoagulant therapy with Coumadin. Another important, but uncommon adverse affect of Coumadin is skin necrosis. Furthermore, many other medications interfere with the metabolism of oral anticoagulants, giving the potential for potentiation or inhibition of its anticoagulant effects.
The AMPLATZER PFO Device offers a potentially simpler, less invasive alternative to traditional surgical methods. It also may allow patients to avoid the potential side effects often associated with anticoagulation therapies. More importantly, the device is designed to seal the defect thus eliminating permanently the passage of thrombi through the communication. We propose to study the safety and efficacy of PFO closures using the AMPLATZER PFO Occluder device in a randomized, multi-center trial.
This is a single arm registry intended to allow subjects who have already experienced at least two cryptogenic strokes and who have failed conventional drug therapy access to the AMPLATZER PFO Occluder device during the time that PFO closure devices are under IDE clinical investigation and FDA regulatory review.
Contact Information
Status:
Name, Phone, Email:
Renee Neuharth, BS
801-587-4877
Renee.Neuharth@hsc.utah.edu
Principle Investigator:
Andrew D. Michaels, MD, MAS, FACC, FAHA
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Participant Eligibility
Inclusion Criteria:[NOTE TO PATIENTS: You may want to copy the following information and present it to your Doctor to determine your eligibility to participate in this study]
Subjects will be considered for enrollment if they have a documented PFO and recurrent cryptogenic stroke on anticoagulant or antiplatelet therapy. Anticoagulant/antiplatelet therapy is defined as therapeutic dose of Coumadin at an INR range 2-3; adequate dosage of aspirin; or adequate dosage of a combination of aspirin and Plavix or Ticlid.
Exclusion Criteria:- Subjects with INR outside the 2-3 range Intracardiac Thrombus (subjects may be enrolled after medical treatment and resolution of the thrombus)
- If a subject has a hypercoagulable state, or cannot take antiplatelet medications, careful consideration must be taken if the subject should be enrolled into the PFO Access study.
