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

Primary Purpose

Atrial Septal Defect, Patent Foramen Ovale

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Solysafe Septal Occluder
Sponsored by
Carag AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Septal Defect

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All Sexes

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)

Sites / Locations

  • German Heart Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 23, 2009
Sponsor
Carag AG
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1. Study Identification

Unique Protocol Identification Number
NCT00207376
Brief Title
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Carag AG

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defect, Patent Foramen Ovale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Solysafe Septal Occluder

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ewert, PD Dr.
Organizational Affiliation
German Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Heart Institute
City
Berlin
ZIP/Postal Code
13353
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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