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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583791
Recruitment Status : Unknown
Verified December 2007 by St. Jude Medical.
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2007
Last Update Posted : July 28, 2009
Information provided by:
St. Jude Medical

Brief Summary:
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 or disease Intervention/treatment Phase
Muscular Ventricular Septal Defects VSD Device: Device closure with the AMPLATZER Muscular VSD Occluder Phase 1

Expanded Access : St. Jude Medical has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2000
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Device: Device closure with the AMPLATZER Muscular VSD Occluder
Device: AMPLATZER Muscular VSD Occluder

Primary Outcome Measures :
  1. Closure of muscular ventricular septal defects [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583791

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
St. Jude Medical

Responsible Party: Ken Lock, AGA Medical Corporation Identifier: NCT00583791     History of Changes
Other Study ID Numbers: AGA-005
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: July 28, 2009
Last Verified: December 2007

Keywords provided by St. Jude Medical: