COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Paradigm I Clinical Trial: Study of the PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemia Attack or Paradoxical Embolism

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: NCT00196027
Recruitment Status : Unknown
Verified November 2006 by Cierra.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2005
Last Update Posted : November 29, 2006
Information provided by:

Brief Summary:
The primary objective of this study is to demonstrate the safety of the PFX Closure System when utilized for patients with patent foramen ovale (PFO) suffering from cryptogenic stroke, transient ischemic attacks or paradoxical embolism.

Condition or disease Intervention/treatment Phase
Patent Foramen Ovale 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 (TIA), 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 40 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 Ischemia Attack or Paradoxical Embolism
Study Start Date : April 2005

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

Secondary Outcome Measures :
  1. PFO closure as measured by TEE or TCD at 30 days post procedure
  2. Neurological death and adverse event (AE) rates for all subjects through 30 day follow-up
  3. New arrhythmia rate through 30 day follow-up. For any subjects with new arrhythmia, arrhythmia status will also be evaluated at a follow-up visit from 3 to 6 months post procedure
  4. PFO closure rate at 3 to 6 months for any subject not demonstrating complete closure at the 30 day follow-up

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 TCD and peri-operative echocardiography or ultrasound.
  • Subjects with a history of cryptogenic stroke, transient ischemic attack or paradoxical embolism due to presumed paradoxical embolism through a PFO.
  • Negative pregnancy test in women who are of child-bearing potential.
  • Signed Informed Consent form.

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 defects or fenestrations which allow right-to-left shunting.
  • Presence of implanted cardiac valves, pacemaker, implantable cardioverters/defibrillators (ICDs) or vena cava filters.
  • Subjects with an intra-cardiac mass, tumor, clot 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 arrhythmia 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.
  • History of stroke or TIA within the past 14 days.
  • Source of stroke other than paradoxical embolization.
  • Hemodynamic instability or shock.
  • Hypercoagulable disorder.
  • Subjects with coagulation disorders who are unable to take antiplatelet or anticoagulant therapy.

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): NCT00196027

Layout table for location information
CardioVascular Center, Sankt katharinen
FrankFurt/Main, Germany
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Horst Sievert, MD Cardio Vasculares Centrum - Sankt Katharien
Layout table for additonal information Identifier: NCT00196027    
Other Study ID Numbers: 2005-001 version 1
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 29, 2006
Last Verified: November 2006
Additional relevant MeSH terms:
Layout table for MeSH terms
Foramen Ovale, Patent
Embolism, Paradoxical
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities