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

Completed · Not applicable

Conditions studied: Heart Septal Defects, Ventricular

In brief

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.

Key facts

Study ID

NCT00583791

Run by

Abbott Medical Devices

People needed

91

Starts

2000-07-01

Expected to finish

2009-11-01

Last updated by the study team

2019-06-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital — Denver, Colorado, United States
• Arnold Palmer Hospital — Orlando, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University Medical Center — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Columbus Children's Hospital — Columbus, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Children's Hospital of the King's Daughters — Norfolk, Virginia, United States
• Children's Hospital and Regional Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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