Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00578708
First received: December 20, 2007
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

The purpose of this feasibility study is to investigate the safety of the AMPLATZER® Membranous VSD Occluder for the treatment of hemodynamically significant Perimembranous Ventricular Septal Defects.


Condition Intervention Phase
Membranous Ventricular Septal Defects
Device: AMPLATZER Membranous VSD Occluder
Phase 1

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 perimembranous Ventricular Septal Defects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: September 2003
Study Completion Date: September 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Device: AMPLATZER Membranous VSD Occluder
Device closure with the AMPLATZER Membranous VSD Occluder

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hemodynamically significant Perimembranous ventricular septal defects

Exclusion Criteria:

  • Patients < 8 kg
  • Supracristal ventricular septal defects
  • Left ventricle to right atrium shunting
  • Prolapse of the aortic valve
  • Right to left shunting through the defect
  • Perimembranous VSD with an aneurysm and multiple shunts which can not be successfully closed with one device
  • Patients with <2mm aortic rim
  • Sepsis (local/generalized)
  • Complex heart lesions such as atrioventricular canal defect or Tetralogy of Fallot.
  • Patients who are ASA intolerant
  • Unable to be followed for the duration of the clinical trial
  • Inability to obtain informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578708

Locations
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
Children's Hospital UN/CU)
Omaha, Nebraska, United States, 68114
United States, New York
Columbia University
New York, New York, United States, 10032
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
Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00578708     History of Changes
Other Study ID Numbers: AGA-008, G020202
Study First Received: December 20, 2007
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
membranous
ventricular
septal
defect
VSD

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 16, 2014