PFx Closure System in Subjects With Cryptogenic Stroke,Transient Ischemic Attack,Migraine or Decompression Illness(PFO) - Full Text View

Sponsored by:	Cierra
Information provided by:	Cierra
ClinicalTrials.gov Identifier:	NCT00335296

Purpose

The primary objective of this study is to demonstrate the 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
Patent Foramen Ovale	Device: PFx catheter

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Migraine Transient Ischemic Attack

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Further study details as provided by Cierra:

Primary Outcome Measures:

PFO closure 6 months post procedure [ Time Frame: 6 months ]

Secondary Outcome Measures:

PFO closure at 30 days and 12 months post procedure [ Time Frame: 30 days, 12 months ]
AE event rates for all subjects [ Time Frame: 30 days, 6 and 12 months ]
Migraine severity [ Time Frame: 6 and 12 months ]

Estimated Enrollment:	100
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2007

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; this study uses a non-implantable system to safely effect closure with the application of radiofrequency energy.

Eligibility

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

Criteria

Inclusion Criteria:

Age between 18 and 65 years old
Documented PFO
Subjects with one or more of the following:cryptogenic stroke, transient ischemic attack, embolism, migraine headaches, decompression illness

Exclusion Criteria:

• Inappropriate 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: NCT00335296

Locations

Belgium
AZ Middleheim Hospital
Antwerpen, Belgium
France
Bichat Hospital
Paris, France, 75877
Institut Hospitalier Jacques Carter
Massy, France
Germany
Cardiovascular Center Frankfurt Sankt katharinen
Frankfurt, Germany, 60389

Sponsors and Collaborators

Cierra

Investigators

Principal Investigator:

Alec Vahanian, MD

Bichat Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	CA0005/09
Study First Received:	June 8, 2006
Last Updated:	December 18, 2007
ClinicalTrials.gov Identifier:	NCT00335296
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Cierra:

PFO
Migraine
Stroke
TIA (transient ischemic attack)
Decompression Illness

Study placed in the following topic categories:

Ischemic Attack, Transient
Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Ischemia
Brain Diseases

Cerebrovascular Disorders
Heart Septal Defects, Atrial
Headache Disorders
Congenital heart septum defect
Migraine Disorders
Foramen Ovale, Patent
Headache
Brain Ischemia
Congenital Abnormalities
Heart Defects, Congenital

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009