Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
- Conditions
- Ventricular Septal Defects
- Interventions
- Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
- Registration Number
- NCT00647387
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) Implantation with the device
- Primary Outcome Measures
Name Time Method Primary Effectiveness End Point: Technical Success During the procedure Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
Primary Effectiveness End Point: Acute Procedure Success At the end of the procedure Acute procedural success was defined as a defect with a ≤ 2mm residual shunt at the conclusion of the procedure, as reported by clinical sites.
Primary Effectiveness End Point: Shunt Closure Success 1-year follow-up visit Subjects in whom a defect has ≤ 2 mm residual shunt at the 1-year follow-up visit (as evaluated by the independent echocardiography board).
Primary Safety Endpoint Within 12 months of the procedure The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Sunrise Hospital
🇺🇸Las Vegas, Nevada, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
St. Joseph Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Joe DiMaggio Children's Hospital
🇺🇸Hollywood, Florida, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Nemours/Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
BC Children's Hospital
🇨🇦Vancouver, Bristish Columbia, Canada
Deborah Heart & Lung Center
🇺🇸Browns Mills, New Jersey, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Methodist LeBonheur Healthcare
🇺🇸Memphis, Tennessee, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Children's Hospital Los Angeles (USC)
🇺🇸Los Angeles, California, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Sparrow Clinical Research Institute
🇺🇸Lansing, Michigan, United States
St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Children's Hospital of New York-Presbyterian
🇺🇸New York, New York, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Hopital Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Children's Hospital of Colorado
🇺🇸Aurora, Colorado, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Arnold Palmer Hospital
🇺🇸Orlando, Florida, United States
University of Missouri-Kansas City School of Medicine
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States