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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by AGA Medical Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583791
First received: December 20, 2007
Last updated: July 24, 2009
Last verified: December 2007
  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 1

AGA Medical Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Ken Lock, AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00583791     History of Changes
Other Study ID Numbers: AGA-005, G990289
Study First Received: December 20, 2007
Last Updated: July 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
muscular
ventricular
septal
defects
VSD

ClinicalTrials.gov processed this record on October 23, 2014