Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases

Condition(s) studied

Investigational drug(s) / intervention(s)

Occlutech muscular ventricular septal defect (mVSD) Occluder: Percutaneous, transcatheter (catheter-based) non-surgical closure of a muscular ventricular septal defect (mVSD) using the Occlutech mVSD Occluder. The device is a self-expandable nitinol wire-mesh occluder with two retention discs connected by a flexible waist and incorporates polyester/PET patches to support defect occlusion and tissue ingrowth. Implantation is performed by experienced operators in a specialized cath lab according to the IFU and local routine; device sizing/selection is guided by imaging (e.g., transthoracic echocardiography, angiography, fluoroscopy). The system is deployed using compatible Occlutech delivery accessories (e.g., Occlutech Pistol Pusher and Occlutech Delivery Set \[ODS v1 or ODS III\], as applicable).

Study summary

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

Primary outcome measure(s)

• Percentage of Participants With at Least One Serious Adverse Device Effect (SADE) Within 12 Months After Occlutech mVSD Implantation — Up to 12 months post-procedure
  Serious Adverse Device Effects (SADEs) include procedure-related death, stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, severe tricuspid regurgitation (TR), severe aortic regurgitation (AR), right ventricular outflow tract obstruction (RVOTO), left ventricular outflow tract obstruction (LVOTO), device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring open-heart surgery.
• Percentage of Participants With Successful Device Implantation and Trivial or No Residual Ventricular Septal Shunt at 12 Months — 12 months post-procedure
  Successful implantation of the Occlutech mVSD Occluder with effective closure defined as reduction of the muscular ventricular septal shunt to trivial or no residual shunt, as assessed by echocardiography.

Trial sites (6)