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

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ClinicalTrials.gov Identifier: NCT00578708
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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 or disease Intervention/treatment Phase
Membranous Ventricular Septal Defects Device: AMPLATZER Membranous VSD Occluder Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2003
Actual Primary Completion Date : March 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Closure of perimembranous Ventricular Septal Defects [ Time Frame: 5 years ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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
St. Jude Medical

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00578708     History of Changes
Other Study ID Numbers: AGA-008
G020202
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by St. Jude Medical:
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