Amplatzer™ Post Approval Study

Clinical Trial Title

Amplatzer™ Post approval study.

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.

Study Details

Clinical Trial Investigator

Clifford J. Kavinsky, MD, PhD

Contact Information

Deanna Aubry

(312) 942-9398    
Deanna_Aubry@rush.edu