NCT00353509

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

First QC Date

July 16, 2006

Last Update Submit

October 8, 2013

Conditions

Atrial Septal Defects

Interventions

Device Closure of a Septal DefectDEVICE

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASD

You may not qualify if:

  • Criteria that exclude catheterization (e.g. too small size, DIC, high risk of bleeding such as coagulation or clotting disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Childen's Hospital

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ida Jovanovic, Prof. Dr.

    University Children's Hospital Belgrade

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2006

First Posted

July 18, 2006

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

SE(1)