Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
VPA
1 other identifier
interventional
92
2 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2024
CompletedResults Posted
Study results publicly available
February 7, 2025
CompletedFebruary 11, 2025
February 1, 2025
16 years
March 27, 2008
January 16, 2025
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Primary Effectiveness End Point: Technical Success
Technical success was defined as successful deployment of the device (Amplatzerâ„¢ 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
Study Arms (1)
Muscular VSD Occluder
EXPERIMENTALImplantation with the device
Interventions
Device
Eligibility Criteria
You may qualify if:
- complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:
- Large volume left to right shunt (Qp/Qs \>2:1),
- Pulmonary hypertension (PA pressure \>50% systemic) and/or
- Clinical symptoms of congestive heart failure
- Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted.
- 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:
- Left ventriculotomy or an extensive right ventriculotomy,
- Failed previous VSD closure,
- Multiple apical and/or anterior muscular VSDs ("Swiss Cheese Septum"), and/or
- Posterior apical VSDs covered by trabeculae.
- Overall medical condition
- Subject/legally authorized representative has signed the informed consent
- Subject/legally authorized representative is willing to complete the follow-up requirements of this study
You may not qualify if:
- Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid)
- Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
- Subjects with perimembranous (close to the aortic valve) VSD
- Subjects with post-infarction VSD
- Subjects who weigh \< 5.2 kg
- Subjects with sepsis (local/generalized)
- Subjects with active bacterial infections
- Subjects with contraindications to anti-platelets
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Palmer, Director of Clinical Programs
- Organization
- Abbott Structural Heart
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2008
First Posted
March 31, 2008
Study Start
March 1, 2008
Primary Completion
February 23, 2024
Study Completion
February 23, 2024
Last Updated
February 11, 2025
Results First Posted
February 7, 2025
Record last verified: 2025-02