Clinical trial NCT00647387: Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
Official title: Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Septal Defects
Keywords: muscular
ventricular
septal
defects
VSD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. complex congenital muscular ventricular septal defects (VSD) of significant size to warrant closure. Subjects must meet at least one of the following:

   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:

1. Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid)
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

Primary outcomes:
measure: Primary Effectiveness End Point: Technical Success
timeFrame: During the procedure
measure: Primary Effectiveness End Point: Acute Procedure Success
timeFrame: At the end of the procedure
measure: Primary Effectiveness End Point: Shunt Closure Success
timeFrame: 1-year follow-up visit
measure: Primary Safety Endpoint
timeFrame: Within 12 months of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles (USC)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Wilmington
country: United States
facility: Nemours/Alfred I. duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: University of Missouri-Kansas City School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital
state: Nevada
city: Browns Mills
country: United States
facility: Deborah Heart & Lung Center
state: New Jersey
city: New York
country: United States
facility: Children's Hospital of New York-Presbyterian
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Methodist LeBonheur Healthcare
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: Bristish Columbia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Hopital Sainte-Justine
state: Quebec
Study officials:
References: