PFx Closure System in Subjects With Cryptogenic Stroke, TIA, Migraine or Decompression Illness

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-12-31

Brief Summary

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The primary object of this study is to demonstrate the continued 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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Conditions

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PFO Stroke Transient Ischemic Attack Migraine Decompression Illness

Keywords

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PFO Stroke Transient Ischemic Attack Migraine 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 Closure System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 65 years old
* PFO with one or more of:

* Cryptogenic stroke,
* TIA or embolism,
* History of severe migraine headaches, or
* History of severe decompression illness.

Exclusion Criteria

* In appropriate 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

Responsible Party

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Cierra, Inc.

Principal Investigators

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Horst Sievert, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Center Frankfurt, Germany

Locations

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Cardiovascular Center Frankfurt Sankt katharinen

Frankfurt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CA0012

Identifier Type: -

Identifier Source: org_study_id