This trial is active, not recruiting.

Conditions muscular, ventricular, septal, defects, vsd
Treatment device closure with the amplatzer muscular vsd occluder
Phase phase 1
Sponsor AGA Medical Corporation
Start date July 2000
End date October 2008
Trial size 100 participants
Trial identifier NCT00583791, AGA-005, G990289


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
device closure with the amplatzer muscular vsd occluder
Device: AMPLATZER Muscular VSD Occluder

Primary Outcomes

Closure of muscular ventricular septal defects
time frame: 5 years

Eligibility Criteria

Male or female participants up to 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in July 2009.
Information provided to ClinicalTrials.gov by AGA Medical Corporation.