N/A
N=91
Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
Heart Septal Defects, Ventricular
Bottom Line
View on ClinicalTrials.gov: NCT00583791 ↗Enrolled (actual)
91
Serious AEs
31.9%
Results posted
Jun 2019
Primary outcome: Primary: Closure of Muscular Ventricular Septal Defects — 91 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device closure with the AMPLATZER Muscular VSD Occluder (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Closure of Muscular Ventricular Septal Defects |
91 | — |
Summary
The objective is to investigate the safety of the AMPLATZER Muscular VSD Occluder for the treatment of muscular ventricular septal defects, which are hemodynamically significant and are either isolated or in conjunction with other congenital heart defects in infants and children.
Eligibility Criteria
Inclusion Criteria
- Patients with hemodynamically significant muscular VSD's (demonstrated by echocardiography or angiography), either isolated or in conjunction with other congenital heart defects
- Age < 18 years old
Exclusion Criteria
- Less than 4 mm distance from the semilunar (aortic and pulmonary) and atrioventricular valves (mitral and tricuspid)
- Patients with severely increased pulmonary vascular resistance above 7 woods units and a right-to-left shunt and documented irreversible pulmonary vascular disease
- Patients with perimembranous (close to the aortic valve) VSD
- Patients < 3 kg
- Patients with sepsis (local/generalized)
- Patients with gastritis, gastric ulcer, duodenal ulcer, bleeding disorders etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months
- Inability to obtain informed consent
Data sourced from ClinicalTrials.gov (NCT00583791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.