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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.
Sponsor:
Information provided by:
Cierra
ClinicalTrials.gov Identifier:
NCT00529945
First received: September 12, 2007
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529945

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

No publications provided

Responsible Party: Peggy McLaughlin, Cierra, Inc.
ClinicalTrials.gov 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:
PFO
Stroke
Transient Ischemic Attack
Migraine
Decompression Illness

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Migraine Disorders
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Headache Disorders, Primary
Headache Disorders

ClinicalTrials.gov processed this record on May 19, 2013