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

Heart Septal Defects, Ventricular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583791
• Other study ID #: AGA-005
• Secondary ID: G990289
• Status: Completed
• Phase: N/A
• Start date: July 2000
• Est. completion date: November 2009

Study information

• Verified date: February 2016
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: November 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of Muscular Ventricular Septal Defects	Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder	5 years