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

February 7, 2025 updated by: Abbott Medical Devices
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Bristish Columbia
      • Vancouver, Bristish Columbia, Canada, V6H3N1
        • BC Children's Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada
        • Hopital Sainte-Justine
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
      • Phoenix, Arizona, United States, 85013
        • St. Joseph Hospital and Medical Center
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles (USC)
      • Madera, California, United States, 93638
        • Valley Children's Hospital
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • San Diego, California, United States, 92123
        • Rady Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06510-3202
        • Yale New Haven Hospital
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Nemours/Alfred I. duPont Hospital for Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Joe DiMaggio Children's Hospital
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • Orlando, Florida, United States, 32806
        • Arnold Palmer Hospital
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Riley Hospital for Children
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
      • Lansing, Michigan, United States, 48912
        • Sparrow Clinical Research Institute
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center Fairview
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • University of Missouri-Kansas City School of Medicine
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sunrise Hospital
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart & Lung Center
    • New York
      • New York, New York, United States, 10032
        • Children's Hospital of New York-Presbyterian
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist LeBonheur Healthcare
    • Texas
      • Dallas, Texas, United States, 75235
        • University Of Texas Southwestern Medical Center At Dallas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Muscular VSD Occluder
Implantation with the device
Device: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness End Point: Technical Success
Time Frame: 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).
During the procedure
Primary Effectiveness End Point: Acute Procedure Success
Time Frame: 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.
At the end of the procedure
Primary Effectiveness End Point: Shunt Closure Success
Time Frame: 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).
1-year follow-up visit
Primary Safety Endpoint
Time Frame: Within 12 months of the procedure
The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.
Within 12 months of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Maren Wagner, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Actual)

February 23, 2024

Study Completion (Actual)

February 23, 2024

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimated)

March 31, 2008

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGA-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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