Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale

NCT ID: NCT00207376

Last Updated: 2009-06-24

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

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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This is a prospective multicenter clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent foramen ovale (PFO).

Detailed Description

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Conditions

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Atrial Septal Defect Patent Foramen Ovale

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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Solysafe Septal Occluder

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ASD
* PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism caused by a PFO

Exclusion Criteria

* Criteria that exclude catheterization (e.g. size too small, disseminated intravascular coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carag AG

INDUSTRY

Sponsor Role lead

Principal Investigators

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Peter Ewert, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

German Heart Institute

Locations

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German Heart Institute

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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04k001

Identifier Type: -

Identifier Source: org_study_id

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