Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study

Status: Active, not recruiting
Location: See all (51) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: No
View:

• 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

Locations
United States
Arizona
Phoenix Children's Hospital
Phoenix
St. Joseph Hospital and Medical Center
Phoenix
California
Cedars-Sinai Medical Center
Los Angeles
Children's Hospital Los Angeles (USC)
Los Angeles
Ronald Reagan UCLA Medical Center
Los Angeles
Valley Children's Hospital
Madera
Stanford University Medical Center
Palo Alto
Rady Children's Hospital
San Diego
Colorado
Children's Hospital of Colorado
Aurora
Connecticut
Yale New Haven Hospital
New Haven
Washington, D.c.
Children's National Medical Center
Washington
Delaware
Nemours/Alfred I. duPont Hospital for Children
Wilmington
Florida
Joe DiMaggio Children's Hospital
Hollywood
Jackson Memorial Hospital
Miami
Arnold Palmer Hospital
Orlando
All Children's Hospital
Saint Petersburg
Georgia
Children's Healthcare of Atlanta
Atlanta
Augusta University
Augusta
Iowa
University of Iowa Hospitals & Clinics
Iowa City
Illinois
University of Chicago Medical Center
Chicago
Advocate Christ Medical Center
Oak Lawn
Indiana
Riley Hospital for Children
Indianapolis
Kentucky
University of Kentucky
Lexington
Maryland
University of Maryland Medical Center
Baltimore
Michigan
Children's Hospital of Michigan
Detroit
Sparrow Clinical Research Institute
Lansing
Munson Medical Center
Traverse City
Minnesota
Children's Hospitals and Clinics of Minnesota
Minneapolis
University of Minnesota Medical Center Fairview
Minneapolis
Mayo Clinic
Rochester
Missouri
University of Missouri-Kansas City School of Medicine
Kansas City
St. Louis Children's Hospital
Saint Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
Duke University Medical Center
Durham
New Jersey
Deborah Heart & Lung Center
Browns Mills
Nevada
Sunrise Hospital
Las Vegas
New York
Children's Hospital of New York-Presbyterian
New York
Ohio
The Cleveland Clinic Foundation
Cleveland
Nationwide Children's Hospital
Columbus
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Methodist LeBonheur Healthcare
Memphis
Texas
University of Texas Southwestern Medical Center at Dallas
Dallas
Texas Children's Hospital
Houston
University of Texas Health Science Center at Houston
Houston
Virginia
University of Virginia Medical Center
Charlottesville
Washington
Seattle Children's Hospital
Seattle
Wisconsin
Children's Hospital of Wisconsin
Milwaukee
Other Locations
Canada
Hopital Sainte-Justine
Montreal
The Hospital for Sick Children
Toronto
BC Children's Hospital
Vancouver
Time Frame
Start Date: March 2008
Estimated Completion Date: August 2025
Participants
Target number of participants: 91
Treatments
Experimental: 1
Implantation with the device
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov

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