- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353509
Safety and Effectiveness Study of the Solysafe Septal Occluder
October 8, 2013 updated by: Carag AG
Prospective Mono-center Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device in Patients With Atrial Septum Defect (ASD)
Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)
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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Belgrade, Serbia, 11000
- University Childen's Hospital
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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
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASD
Exclusion Criteria:
- Criteria that exclude catheterization (e.g. too small size, 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: Ida Jovanovic, Prof. Dr., University Children's Hospital Belgrade
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
July 16, 2006
First Submitted That Met QC Criteria
July 16, 2006
First Posted (Estimate)
July 18, 2006
Study Record Updates
Last Update Posted (Estimate)
October 9, 2013
Last Update Submitted That Met QC Criteria
October 8, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006.1621
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 Defects
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W.L.Gore & AssociatesCompleted
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Occlutech International ABCompletedSecundum Atrial Septal Defects
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Henry Ford Health SystemWithdrawn
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University Hospital, ToulousePhilips HealthcareCompleted
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Asklepion Pharmaceuticals, LLCCompletedAtrial Septal Defect | Atrioventricular Septal Defect | Ventricular Septal DefectUnited States
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Institute of Cardiology, Warsaw, PolandUnknownOstium Secundum Atrial Septal DefectPoland
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Ain Shams UniversityCompletedHeart Defects, CongenitalEgypt
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Skane University HospitalCompletedCongenital Heart Disease
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Chinese University of Hong KongRecruiting
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University of California, Los AngelesWithdrawnCosmetics, Suture, CicatrixUnited States
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The Cleveland ClinicTerminatedParastomal HerniaUnited States