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

NCT ID: NCT00335296

Last Updated: 2007-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patent Foramen Ovale

Keywords

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PFO Migraine Stroke TIA (transient ischemic attack) Decompression Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PFx catheter

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cierra

INDUSTRY

Sponsor Role lead

Principal Investigators

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Alec Vahanian, MD

Role: PRINCIPAL_INVESTIGATOR

Bichat Hospital

Locations

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AZ Middleheim Hospital

Antwerp, , Belgium

Site Status

Institut Hospitalier Jacques Carter

Massy, , France

Site Status

Bichat Hospital

Paris, , France

Site Status

Cardiovascular Center Frankfurt Sankt katharinen

Frankfurt, , Germany

Site Status

Countries

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Belgium France Germany

Other Identifiers

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CA0005/09

Identifier Type: -

Identifier Source: org_study_id