Clinical trial NCT00583791: Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Official title: Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Septal Defects, Ventricular
Keywords: muscular
ventricular
septal
defects
VSD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-12-31
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Closure of Muscular Ventricular Septal Defects
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Children's Hospital
state: Colorado
city: Orlando
country: United States
facility: Arnold Palmer Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Columbus
country: United States
facility: Columbus Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: Daniel Levi, MD
role: PRINCIPAL_INVESTIGATOR
References: