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Safety 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
Carag AG
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Septal Defects

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 16, 2006
Last Updated
October 8, 2013
Sponsor
Carag AG
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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
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

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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