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PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness (Paradigm IV)

This study has suspended participant recruitment.
Information provided by:
Cierra Identifier:
First received: September 12, 2007
Last updated: December 18, 2007
Last verified: December 2007
The primary object of this study is to demonstrate the continued safety and performance of the PFx Closure System when utilized for patients with PFOs suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.

Condition Intervention
PFO Stroke Transient Ischemic Attack Migraine Decompression Illness Device: PFx Closure System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Paradigm IV Trial - PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Resource links provided by NLM:

Further study details as provided by Cierra:

Primary Outcome Measures:
  • PFO closure at 6 months post procedure. [ Time Frame: 6 months post procedure ]

Secondary Outcome Measures:
  • PFO closure at 30 days and 12 months post procedure. AE event rate for all subjects. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine. [ Time Frame: 30 days; 6 and 12 months ]

Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Study Completion Date: December 2007

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 to 65 years old
  • PFO with one or more of:

    • Cryptogenic stroke,
    • TIA or embolism,
    • History of severe migraine headaches, or
    • History of severe decompression illness.

Exclusion Criteria:

  • In appropriate anatomy (vascular or cardiac) or inappropriate medical condition for PFO closure and study medications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00529945

Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, Germany, 60389
Sponsors and Collaborators
Principal Investigator: Horst Sievert, MD Cardiovascular Center Frankfurt, Germany
  More Information

Responsible Party: Peggy McLaughlin, Cierra, Inc. Identifier: NCT00529945     History of Changes
Other Study ID Numbers: CA0012
Study First Received: September 12, 2007
Last Updated: December 18, 2007

Keywords provided by Cierra:
Transient Ischemic Attack
Decompression Illness

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Migraine Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Headache Disorders, Primary
Headache Disorders processed this record on September 19, 2017