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

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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.
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
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

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness End Point: Technical Success	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).
Primary Effectiveness End Point: Acute Procedure Success	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.
Primary Effectiveness End Point: Shunt Closure Success	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).
Primary Safety Endpoint	Within 12 months of the procedure	The proportion of subjects who experienced a serious adverse event (SAE) within 12 months of the procedure.

Secondary Outcome Measures

Name	Time	Method

Locations (51): St. Joseph Hospital and Medical Center
🇺🇸
Phoenix, Arizona, United States
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
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St. Joseph Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States