Status:
COMPLETED
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Ventricular Septal Defects
Eligibility:
All Genders
Phase:
NA
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 im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00647387
Start Date
March 1 2008
End Date
February 23 2024
Last Update
February 11 2025
Active Locations (51)
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1
St. Joseph Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Children's Hospital Los Angeles (USC)
Los Angeles, California, United States, 90027
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048