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The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00196040
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 24, 2007
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Brief Summary:
The primary objective of this study is to demonstrate the safety and efficacy of the PFX Closure System when utilized for patent foramen ovale (PFO) in patients suffering from cryptogenic stroke (undetermined cause of stroke), transient ischemic attack (brief neurological dysfunction), migraine or decompression illness.

Condition or disease Intervention/treatment Phase
Foramen Ovale, Patent Device: PFX Closure System Not Applicable

Detailed Description:
Patent Foramen Ovale has been implicated in the etiology of paradoxical embolism, cryptogenic stroke, transient ischemic attack, and right to left gas embolism in severe decompression illness. An association between patent foramen ovale and severe migraine headaches has also been reported. Several implantable devices are being used for percutaneous closure of patent foramen ovale; we propose to use a non-implantable system to safely effect closure.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness
Study Start Date : October 2005
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Primary Outcome Measures :
  1. PFO closure as measured by transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) acutely post procedure

Secondary Outcome Measures :
  1. PFO closure as measured by TEE or transthoracic echocardiography (TTE) at 30 days, 3 or 6 months and 12 months post procedure
  2. Adverse event (AE) rates for all subjects
  3. New conduction abnormality rate through final follow-up
  4. Measurement of migraine severity or frequency at 6 and 12 months post procedure for subjects enrolled due to diagnosis of migraine

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Subject is between 18 and 65 years old
  • Documented patent foramen ovale as determined by positive micro bubble study demonstrating right to left shunt and/or anatomic detection and functional assessment by pre-operative transcranial Doppler (TCD) and peri-operative echocardiography or ultrasound.
  • Subjects with one or more of the following:

    • history of cryptogenic stroke, transient ischemic attack (TIA) or embolism due to presumed paradoxical embolism through a PFO; or
    • history of severe migraine headaches, despite attempted treatment with available migraine medications, for whom other specific causes of migraine headache, such as underlying disease or medications, have been ruled out; or
    • history of severe decompression illness.
  • Negative pregnancy test in women who are of child-bearing potential
  • Signed Informed Consent form

Additional Inclusion Criteria for Migraine Subjects:

  • Onset of migraine before age of 50 years
  • History of migraine > 1 year
  • Migraine frequency greater than 1 migraine per month

Exclusion Criteria:

  • Presence of thrombus at the intended site of closure, in left atrial appendage, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained.
  • Active endocarditis, or other infections producing a bacteremia
  • Presence of atrial septal defect(s) or fenestrations which allow shunting
  • Presence of implanted cardiac valves, pacemakers, cardioverters/defibrillators (ICDs) or vena cava filters.
  • Subjects with coagulation disorders or bleeding disorders including gastric ulcers, who are unable to take antiplatelet or anticoagulant therapy
  • Subjects with an intra-cardiac mass, tumor, clots or vegetation
  • Large, redundant atrial septal aneurysm that would prohibit adequate device access to the PFO or closure of the PFO, in the judgment of the investigator. A coexisting redundant atrial septal aneurysm is considered large if it prohibits the ability of the operator to adequately achieve vacuum suction necessary to achieve PFO closure.
  • Presence of conduction abnormality requiring pharmacologic or electrical therapy intervention or 1st degree block
  • Current enrollment in any investigational trial(s) using devices implanted in the vascular system or enrolled in any experimental drug study(ies) within three months of study entry
  • Religious or other beliefs which would prevent subjects from following all physician directed instructions or prevent compliance with protocol required medications and follow-ups.
  • Hemodynamic instability or shock
  • History of diabetes requiring treatment with insulin

Additional Exclusion Criteria for Cryptogenic Stroke Subjects:

  • History of stroke or TIA within the past 14 days
  • Source of stroke other than paradoxical embolization

Additional Exclusion Criteria for Migraine Subjects:

  • Seizure disorder
  • Other organic central nervous system disease
  • Headache as a result of traumatic head or neck injury
  • Evidence of alcohol, drug or substance abuse within the previous year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00196040

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Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, Germany, 60389
Sponsors and Collaborators
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Principal Investigator: Horst Sievert, MD Cardio Vasculares Centrum - Sankt Katharinen
Layout table for additonal information Identifier: NCT00196040    
Other Study ID Numbers: 2005-002
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 24, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Ischemic Stroke
Foramen Ovale, Patent
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Ischemia
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities