Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott Medical Devices
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. 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),
4. Banding of the pulmonary artery(ies) and in the opinion of the treating investigator closure of the VSD is clinically warranted.
2. 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,
3. Subject/legally authorized representative has signed the informed consent
4. Subject/legally authorized representative is willing to complete the follow-up requirements of this study
You may not be if
1. Subjects with defects less than 4 mm distance from the semilunar (aortic and pulmonary) or atrioventricular valves (mitral and tricuspid)
2. Subjects with severely increased pulmonary vascular resistance above 7 Wood units and a right-to-left shunt and documented irreversible pulmonary vascular disease
3. Subjects with perimembranous (close to the aortic valve) VSD
4. Subjects with post-infarction VSD
5. Subjects who weigh \< 5.2 kg
6. Subjects with sepsis (local/generalized)
7. Subjects with active bacterial infections
8. Subjects with contraindications to anti-platelets
Clareo Health | Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
