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

Completed · Not applicable

Conditions studied: Ventricular Septal Defects

In brief

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.

Key facts

Study ID

NCT00647387

Run by

Abbott Medical Devices

People needed

92

Starts

2008-03-01

Expected to finish

2024-02-23

Last updated by the study team

2025-02-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital Los Angeles (USC) — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Children's Hospital of Colorado — Aurora, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Arnold Palmer Hospital — Orlando, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• St. Joseph Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.