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

Abbott

Status: Completed

Conditions: Heart Septal Defects, Ventricular

Treatments: Device: Device closure with the AMPLATZER Muscular VSD Occluder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00583791

G990289

AGA-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 91 patients

Sex: All

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Main Cohort

Experimental group

Description:

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.

Treatment:

Device: Device closure with the AMPLATZER Muscular VSD Occluder