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Amplatzer™ Post Approval Study

Clinical Trial Title: 
Amplatzer™ Post approval study.
Clinical Trial Protocol ID: 
17102601
Clinical Trial Investigator Name: 
Clifford J. Kavinsky, MD, PhD
Clinical Trial Protocol Description: 

This clinical study is intended to demonstrate the safety and effectiveness of the FDA-approved Amplatzer™ PFO Occluder device, in a post approval setting, in patients with a patent foramen ovale (PFO) who have had a cryptogenic stroke confirmed by a study neurologist.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a PFO.
  • Have a history of ischemic stroke (determined to be cryptogenic by a neurologist) within 547 days prior to signing the informed consent form.
  • Are 18-60 years old.

You will be excluded from the study if any of the following criteria apply to you:

  • Have had a recent heart attack.
  • Have mitral or aortic valve stenosis, or prosthesis.

This is a partial list of inclusion and exclusion criteria. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.

Clinical Trial Area: 
Heart and Vascular Conditions
Stroke and Cerebrovascular Disease
Contact Email: 
Contact Phone: 
(312) 942-9398
Contact Name: 
Deanna Aubry