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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.
 
ClinicalTrials.gov Identifier: NCT00583791
Recruitment Status : Completed
First Posted : December 31, 2007
Results First Posted : June 28, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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Brief Summary:
The objective 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
Heart Septal Defects, Ventricular Device: Device closure with the AMPLATZER Muscular VSD Occluder Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Study Start Date : July 2000
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Main Cohort
Device closure with the AMPLATZER Muscular VSD Occluder for patients with muscular ventricular septal defects which are hemodynamically significant and are either isolated or present in conjunction with other congenital heart defects.
 Device: Device closure with the AMPLATZER Muscular VSD Occluder
Device: AMPLATZER Muscular VSD Occluder


Outcome Measures
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Primary Outcome Measures :
  1. Closure of Muscular Ventricular Septal Defects [ Time Frame: 5 years ]
    Closure of muscular ventricular septal defect with the AMPLATZER Muscular VSD Occluder


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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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): NCT00583791


Locations
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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
Saint 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
Abbott Medical Devices
Investigators
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Principal Investigator: Daniel Levi, MD University of California, Los Angeles
More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00583791    
Other Study ID Numbers: AGA-005
G990289
First Posted: December 31, 2007    Key Record Dates
Results First Posted: June 28, 2019
Last Update Posted: June 28, 2019
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Abbott Medical Devices:
muscular
ventricular
septal
defects
VSD
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Ventricular
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities