Back to resultsSafety and Effectiveness Study of the Solysafe Septal Occluder
Primary Purpose
Atrial Septal Defects
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Device Closure of a Septal Defect
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Septal Defects
Eligibility Criteria
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)
Sites / Locations
- University Childen's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00353509
Brief Title
Safety and Effectiveness Study of the Solysafe Septal Occluder
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
October 2013
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
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carag AG
4. Oversight
5. Study Description
Brief Summary
Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Septal Defects
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)
Device Closure of a Septal Defect
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ida Jovanovic, Prof. Dr.
Organizational Affiliation
University Children's Hospital Belgrade
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Childen's Hospital
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness Study of the Solysafe Septal Occluder
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