A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects

A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Perimembranous Ventricular Septal Defect (PmVSD) Occluder in Patients With Perimembranous Ventricular Septal Defects

The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.

Inclusion Criteria:

Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum

Exclusion Criteria:

Occlutech® PmVSD Occluder is contraindicated for the following:

• Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves
• Patients less than 10.0 kg
• Patients with sepsis (local or generalized)
• Patients with left ventricle to right atrial shunting
• Patients with right to left shunting through the defect
• Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device
• Patients with complex heart lesions such as tetralogy of fallot
• History of repeated pulmonary infection
• Any type of serious infection 1 month prior to procedure
• Malignancy where life expectancy is less than 3 years
• Demonstrated intracardiac thrombi on echocardiography
• Patients with allergy to anti-platelet or anticoagulant therapy
• Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials
• Patients with intolerance to contrast agents
• Patients with active bacterial infections
• Patients with very small vessels which are not suitable for recommended delivery sheath sizes