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

Primary Purpose

Ventricular Septal Defects

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Septal Defects focused on measuring muscular, ventricular, septal, defects, VSD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph Hospital and Medical Center
  • Phoenix Children's Hospital
  • Children's Hospital Los Angeles (USC)
  • Cedars-Sinai Medical Center
  • Ronald Reagan UCLA Medical Center
  • Valley Children's Hospital
  • Stanford University Medical Center
  • Rady Children's Hospital
  • Children's Hospital of Colorado
  • Yale New Haven Hospital
  • Nemours/Alfred I. duPont Hospital for Children
  • Children's National Medical Center
  • Joe DiMaggio Children's Hospital
  • Jackson Memorial Hospital
  • Arnold Palmer Hospital
  • All Children's Hospital
  • Children's Healthcare of Atlanta
  • Augusta University
  • University of Chicago Medical Center
  • Advocate Christ Medical Center
  • Riley Hospital for Children
  • University of Iowa Hospitals & Clinics
  • University of Kentucky
  • University of Maryland Medical Center
  • Children's Hospital of Michigan
  • Sparrow Clinical Research Institute
  • Munson Medical Center
  • Children's Hospitals and Clinics of Minnesota
  • University of Minnesota Medical Center Fairview
  • Mayo Clinic
  • University of Mississippi Medical Center
  • University of Missouri-Kansas City School of Medicine
  • St. Louis Children's Hospital
  • Sunrise Hospital
  • Deborah Heart & Lung Center
  • Children's Hospital of New York-Presbyterian
  • University of North Carolina at Chapel Hill
  • Duke University Medical Center
  • The Cleveland Clinic Foundation
  • Nationwide Children's Hospital
  • Medical University of South Carolina
  • Methodist LeBonheur Healthcare
  • University of Texas Southwestern Medical Center at Dallas
  • Texas Children's Hospital
  • University of Texas Health Science Center at Houston
  • University of Virginia Medical Center
  • Seattle Children's Hospital
  • Children's Hospital of Wisconsin
  • BC Children's Hospital
  • The Hospital for Sick Children
  • Hopital Sainte-Justine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Implantation with the device

Outcomes

Primary Outcome Measures

The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. Subjects will be followed for 5 years post implant.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2008
Last Updated
September 28, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00647387
Brief Title
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
Acronym
VPA
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2008 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Septal Defects
Keywords
muscular, ventricular, septal, defects, VSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Implantation with the device
Intervention Type
Device
Intervention Name(s)
Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Intervention Description
Device
Primary Outcome Measure Information:
Title
The primary safety objective is to evaluate the proportion of subjects experiencing a major adverse event within 12 months of the procedure. Subjects will be followed for 5 years post implant.
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maren Wagner
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Children's Hospital Los Angeles (USC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93638
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Children's Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510-3202
Country
United States
Facility Name
Nemours/Alfred I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Arnold Palmer Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Medical Center Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University of Missouri-Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Sunrise Hospital
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Deborah Heart & Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Children's Hospital of New York-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist LeBonheur Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
Bristish Columbia
ZIP/Postal Code
V6H3N1
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Hopital Sainte-Justine
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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