Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
NCT ID: NCT00647387
Last Updated: 2025-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
92 participants
INTERVENTIONAL
2008-03-31
2024-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Muscular VSD Occluder
Implantation with the device
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Device
Interventions
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Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Device
Eligibility Criteria
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Inclusion Criteria
1. Large volume left to right shunt (Qp/Qs \>2:1),
2. Pulmonary hypertension (PA pressure \>50% systemic) and/or
3. Clinical symptoms of congestive heart failure
4. Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted.
2. Subjects must meet at least one of the following criteria to be considered high risk for standard transatrial or transarterial surgical closure based on anatomical conditions:
1. Left ventriculotomy or an extensive right ventriculotomy,
2. Failed previous VSD closure,
3. Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
4. Posterior apical VSDs covered by trabeculae.
5. Overall medical condition
3. Subject/legally authorized representative has signed the informed consent
4. Subject/legally authorized representative is willing to complete the follow-up requirements of this study
Exclusion Criteria
2. Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
3. Subjects with perimembranous (close to the aortic valve) VSD
4. Subjects with post-infarction VSD
5. Subjects who weigh \< 5.2 kg
6. Subjects with sepsis (local/generalized)
7. Subjects with active bacterial infections
8. Subjects with contraindications to anti-platelets
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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St. Joseph Hospital and Medical Center
Phoenix, Arizona, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital Los Angeles (USC)
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Arnold Palmer Hospital
Orlando, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Sunrise Hospital
Las Vegas, Nevada, United States
Deborah Heart & Lung Center
Browns Mills, New Jersey, United States
Children's Hospital of New York-Presbyterian
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist LeBonheur Healthcare
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
BC Children's Hospital
Vancouver, Bristish Columbia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Hopital Sainte-Justine
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AGA-016
Identifier Type: -
Identifier Source: org_study_id
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