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

Ventricular Septal Defects Clinical Trial

— VPA  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00647387
• Other study ID #: AGA-016
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2008
• Est. completion date: August 2025

Study information

• Verified date: February 2024
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 91
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Ventricular Septal Defects

Intervention

Device:
• Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Device

Locations

Country	Name	City	State
Canada	Hopital Sainte-Justine	Montreal	Quebec
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Children's Hospital	Vancouver	Bristish Columbia
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	Children's Hospital of Colorado	Aurora	Colorado
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Deborah Heart & Lung Center	Browns Mills	New Jersey
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 Virginia Medical Center	Charlottesville	Virginia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Joe DiMaggio Children's Hospital	Hollywood	Florida
United States	Texas Children's Hospital	Houston	Texas
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinics	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	University of Missouri-Kansas City School of Medicine	Kansas City	Missouri
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Sunrise Hospital	Las Vegas	Nevada
United States	University of Kentucky	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Children's Hospital Los Angeles (USC)	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	Valley Children's Hospital	Madera	California
United States	Methodist LeBonheur Healthcare	Memphis	Tennessee
United States	Jackson Memorial Hospital	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota Medical Center Fairview	Minneapolis	Minnesota
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Children's Hospital of New York-Presbyterian	New York	New York
United States	Advocate Christ Medical Center	Oak Lawn	Illinois
United States	Arnold Palmer Hospital	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	St. Joseph Hospital and Medical Center	Phoenix	Arizona
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	All Children's Hospital	Saint Petersburg	Florida
United States	Rady Children's Hospital	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Munson Medical Center	Traverse City	Michigan
United States	Children's National Medical Center	Washington	District of Columbia
United States	Nemours/Alfred I. duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months