This is a multicenter, International, follow-up registry to monitor the efficacy and safety of the Occlutech® mVSD in patients with muscular ventricular septal defects.~Efficacy and safety of implanted device(s) will be assessed by vital signs, laboratory test, ECGs, and echocardiography on Day 1 (within 36 hrs. post procedure), Day 30, day 60, 6 months and 1 year after the implantation.~Patients will be treated according to the instruction-for-use of the device and according to clinical routine~Patients will be screened to determine eligibility for the registry based on inclusion/exclusion criteria, through their medical history, demographics, vital signs, clinical laboratory tests, performance of a 12 lead electrocardiogram (ECG) and echocardiography data.~Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedure will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease, including transseptal puncture, anterograde, retrograde or transapical device delivery approaches.~Registry will be open for the next two years or when up to 100 patients are enrolled (whatever comes first)~The primary efficacy endpoints will include data obtained 1 year after mVSD closure procedure for successful implantation of the device with a proper closure of the mVSD (defined as Reduction in muscular ventricular septal regurgitation of ≥ one grade as assessed by echocardiography pre vs post implantation) and/or reduction in the number of hemolysis related transfusions.~The primary safety endpoint is defined as absence of Serious Adverse Events (SAEs) 1 years after mVSD closure procedure.
The Occlutech® mVSD is indicated for percutaneous, transcatheter muscular ventricular septal defect closure device designed for the occlusion of hemodynamically significant muscular ventricular septal defects.~The objectives of the study are:~To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.~To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.