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
Transient Ischemic Attack
Decompression Illness
Device: PFx Closure System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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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

No publications provided

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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cierra:
Transient Ischemic Attack
Decompression Illness

Additional relevant MeSH terms:
Ischemic Attack, Transient
Brain Ischemia
Migraine Disorders
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Pathologic Processes
Vascular Diseases processed this record on October 09, 2015