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Safety and Effectiveness Study of the Solysafe Septal Occluder

Prospective Mono-center Clinical Study to Evaluate the Safety and Effectiveness of an Intracardiac Septal Closure Device in Patients With Atrial Septum Defect (ASD)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00353509
Enrollment
Unknown
Registered
2006-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2013-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Septal Defects

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)

Interventions

DEVICEDevice Closure of a Septal Defect

Sponsors

Carag AG
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

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)

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026