A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects
The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically 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.
• A participant will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.
• Any age
• Male or female.
• Patients understand the nature of the study and provide their informed consent to participation.
• Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP.
⁃ Contraindication
• Hemodynamically relevant VSD shunt
• Congestive heart insufficiency
• Recurrent respiratory infections
• Failure to thrive.
• Significant left ventricle (LV) enlargement
• Significant left atrium (LA) enlargement
• Other clinical indication