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

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
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 October 14, 2008

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