Safety and Effectiveness Study of the Solysafe Septal Occluder
Information source: Carag AG
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Septal Defects
Intervention: Device Closure of a Septal Defect (Device)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Carag AG Official(s) and/or principal investigator(s):
Ida Jovanovic, Prof. Dr., Principal Investigator, Affiliation: University Children's Hospital Belgrade
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)
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
University Childen's Hospital, Belgrade 11000, Serbia and Montenegro
Additional Information
Last updated: October 16, 2007
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