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

Patent Foramen Ovale Clinical Trial

Official title:

The Paradigm IIca/III Trial: PFx Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00335296
• Other study ID #: CA0005/09
• Status: Suspended
• Phase: N/A
• First received: June 8, 2006
• Last updated: December 18, 2007
• Start date: May 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2007
• Source: Cierra
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Ischemic Attack, Transient
• Patent Foramen Ovale

Intervention

Device:
• PFx catheter

Locations

Country	Name	City	State
Belgium	AZ Middleheim Hospital	Antwerpen
France	Institut Hospitalier Jacques Carter	Massy
France	Bichat Hospital	Paris
Germany	Cardiovascular Center Frankfurt Sankt katharinen	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Cierra

Countries where clinical trial is conducted

Belgium,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFO closure 6 months post procedure		6 months
Secondary	PFO closure at 30 days and 12 months post procedure		30 days, 12 months
Secondary	AE event rates for all subjects		30 days, 6 and 12 months
Secondary	Migraine severity		6 and 12 months

External Links

•   Link