Safety and Effectiveness Study of the Solysafe Septal Occluder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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Prospective mono-center clinical study to evaluate the safety and effectiveness of an intracardiac septal closure device in patients with atrial septum defect (ASD)

Detailed Description

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Conditions

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Atrial Septal Defects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Device Closure of a Septal Defect

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ida Jovanovic, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital Belgrade

Locations

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University Childen's Hospital

Belgrade, , Serbia

Site Status

Countries

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Serbia and Montenegro Serbia

Other Identifiers

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2006.1621

Identifier Type: -

Identifier Source: org_study_id