Back to resultsSafety 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
About this trial
This is an interventional treatment trial for Atrial Septal Defect
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)
Sites / Locations
- German Heart Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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