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

This study is ongoing, but not recruiting participants.

Sponsored by:	AGA Medical Corporation
Information provided by:	AGA Medical Corporation
ClinicalTrials.gov Identifier:	NCT00583791

Purpose

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.

Condition	Intervention	Phase
Muscular Ventricular Septal Defects VSD	Device: Device closure with the AMPLATZER Muscular VSD Occluder	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:

Closure of muscular ventricular septal defects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	July 2000
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Device closure with the AMPLATZER Muscular VSD Occluder Device: AMPLATZER Muscular VSD Occluder

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583791

Locations

United States, Colorado
Children's Hospital
Denver, Colorado, United States, 80218
United States, Florida
Arnold Palmer Hospital
Orlando, Florida, United States, 32806
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109-0316
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2045
United States, Ohio
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 30322
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105

Sponsors and Collaborators

AGA Medical Corporation

More Information

FDA PMA Approval This link exits the ClinicalTrials.gov site

Responsible Party:	AGA Medical Corporation ( Ken Lock )
Study ID Numbers:	AGA-005, G990289
Study First Received:	December 20, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00583791
Health Authority:	United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

muscular
ventricular
septal
defects
VSD

Study placed in the following topic categories:

Heart Septal Defects
Heart Diseases
Congenital heart septum defect
Cardiovascular Abnormalities

Heart Septal Defects, Ventricular
Ventricular septal defects
Congenital Abnormalities
Heart Defects, Congenital

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009