Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
The objective of this feasibility study 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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Closure of Muscular Ventricular Septal Defects With The AMPLATZER™ Muscular VSD Occluder
