- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00207376
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
June 23, 2009 updated by: Carag AG
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)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 13353
- German Heart Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Ewert, PD Dr., German Heart Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 24, 2009
Last Update Submitted That Met QC Criteria
June 23, 2009
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04k001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Septal Defect
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Assiut UniversityWithdrawnASD2(Secundum Atrial Septal Defect)
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W.L.Gore & AssociatesCompletedSeptal Defect, AtrialUnited States
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Occlutech International ABCompletedSecundum Atrial Septal Defects
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Asklepion Pharmaceuticals, LLCCompletedAtrial Septal Defect | Atrioventricular Septal Defect | Ventricular Septal DefectUnited States
-
Ayman khairy MohamedCompletedAtrial Septal Defect, Secundum TypeEgypt
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Abbott Medical DevicesTerminatedAtrial Septal Defect SecundumUnited States
-
Nobles Medical Technologies II IncEnrolling by invitationForamen Ovale, Patent | Septal Defect, Atrial | Septal Defect, HeartUnited States, Italy
-
HeartStitch.ComUnknownForamen Ovale, Patent | Septal Defect, Atrial | Septal Defect, HeartUnited States
-
W.L.Gore & AssociatesCompleted
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Abbott Medical DevicesRecruitingPFO - Patent Foramen Ovale | VSD - Muscular Ventricular Septal Defect | PIVSD - Post Infarct Muscular Ventricular Septal Defect | ASD - Atrial Septal DefectSpain, Germany, Poland, France, Italy, Netherlands, Switzerland
Clinical Trials on Solysafe Septal Occluder
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Abbott Medical DevicesTerminatedAtrial Septal Defect SecundumUnited States
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University of Sao PauloW.L.Gore & Associates; InCor Heart InstituteTerminatedAcquired Tracheo-esophageal FistulaBrazil
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Abbott Medical DevicesCompletedAtrial Septal DefectUnited States
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W.L.Gore & AssociatesRecruitingStroke | TIA | Cryptogenic Stroke | PFO - Patent Foramen OvaleJapan
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W.L.Gore & AssociatesCompletedSeptal Defect, AtrialUnited States
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W.L.Gore & AssociatesCompleted
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W.L.Gore & AssociatesRecruitingStroke | PFO - Patent Foramen OvaleUnited States
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University Health Network, TorontoSt. Paul's Hospital, Canada; Montreal Heart Institute; Centre de Recherche de...RecruitingAtrial Septal DefectCanada
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Nobles Medical Technologies II IncEnrolling by invitationForamen Ovale, Patent | Septal Defect, Atrial | Septal Defect, HeartUnited States, Italy
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Gachon University Gil Medical CenterCompletedPatent Foramen Ovale | Closure; Foramen OvaleKorea, Republic of