NCT00647387|CompletedResultsDMC
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
VPA
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Sponsor study identifier
interventional
92
2 countries
51
Study Start
March 2008
Actual (reported)Primary Completion
February 23, 2024
Actual (reported)Study Completion
February 23, 2024
Actual (reported)The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 23, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Actual (reported)March 27, 2008
Actual (reported)March 31, 2008
Actual (reported)February 23, 2024
Actual (reported)February 23, 2024
Actual (reported)February 7, 2025
Actual (reported)Primary Effectiveness End Point: Technical Success
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
During the procedure
Primary Effectiveness End Point: Acute Procedure Success
Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
At the end of the procedure
Primary Effectiveness End Point: Shunt Closure Success
Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
1-year follow-up visit
Primary Safety Endpoint
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
Within 12 months of the procedure
Implantation with the device
Device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St. Joseph Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital Los Angeles (USC)
Los Angeles, California, 90027, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Valley Children's Hospital
Madera, California, 93638, United States
Stanford University Medical Center
Qureshi AM, Justino H, Owada C, Numan M, Ebeid M, Forbes TJ, Nykanen D, Kobayashi D, Kolles J, Gutfinger D, Balzer D. Postapproval Study Outcomes of Muscular Ventricular Septal Defect Closure With the Amplatzer Muscular VSD Occluder. Circ Cardiovasc Interv. 2026 Jun;19(6):e016121. doi: 10.1161/CIRCINTERVENTIONS.125.016121. Epub 2026 May 5.
92 participants (actual enrollment reported by the registry).
First Submitted
March 27, 2008
First Posted
March 31, 2008
Study Start
March 2008
Actual (reported)Primary Completion
Bypass Clear Priming VSD Cardiopulmonary Bypass Circuit Reduce Bypass Associated Inflammation?
Contact the study team to confirm eligibility.
Palo Alto, California, 94304, United States
Rady Children's Hospital
San Diego, California, 92123, United States
Children's Hospital of Colorado
Aurora, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510-3202, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Arnold Palmer Hospital
Orlando, Florida, 32806, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Augusta University
Augusta, Georgia, 30912, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Sunrise Hospital
Las Vegas, Nevada, 89109, United States
Deborah Heart & Lung Center
Browns Mills, New Jersey, 08015, United States
Children's Hospital of New York-Presbyterian
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Methodist LeBonheur Healthcare
Memphis, Tennessee, 38104, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
BC Children's Hospital
Vancouver, Bristish Columbia, V6H3N1, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Hopital Sainte-Justine
Montreal, Quebec, Canada
February 23, 2024
Actual (reported)Study Completion
February 23, 2024
Actual (reported)Last Updated
February 11, 2025
Results First Posted
February 7, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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