Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder

Study Overview
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Brief Summary
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The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.

Detailed Description
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The objective of this feasibility study is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.

Official Title
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Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder

Conditions
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Heart Septal Defects, Ventricular

Intervention / Treatment
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* Device: Device closure with the AMPLATZER Muscular VSD Occluder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hemodynamically significant muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects Age < 18 years old Exclusion Criteria: Less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid) Patients with severely increased pulmonary vascular resistance above 7 woods units and a right-to-left shunt and documented irreversible pulmonary vascular disease Patients with perimembranous (close to the aortic valve) VSD Patients < 3 kg Patients with sepsis (local/generalized) Patients with gastritis, gastric ulcer, duodenal ulcer, bleeding disorders etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months Inability to obtain informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main Cohort<br>Device closure with the AMPLATZER Muscular VSD Occluder for patients with muscular ventricular septal defects which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects. | Device: Device closure with the AMPLATZER Muscular VSD Occluder<br>* Device: AMPLATZER Muscular VSD Occluder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of Muscular Ventricular Septal Defects | Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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muscular, ventricular, septal, defects, VSD