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

NCT05329350 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-02-02

No results posted yet for this 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.

Conditions

  • Muscular Ventricular Septal Defect

Interventions

DEVICE

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).

Sponsors & Collaborators

  • Occlutech International AB

    lead INDUSTRY

Eligibility

Min Age
3 Months
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2026-03-03
Completion
2029-10-01

Countries

  • Ireland
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05329350 on ClinicalTrials.gov