About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Active infection at the time of implantation
Allergy to antiplatelet or anticoagulant therapy
Allergy to nickel and/or titanium and/or nickel/titanium-based materials
Any type of serious infection 1 month before the procedure
Trial design
Treatments tested in this trial
- Occlutech muscular ventricular septal defect (mVSD) Occluder