Clinical Trial

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

Study acronym: mVSD Registry
Recruiting
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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.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-07-31
notable Primary completion pushed: 2026-03-03 -> 2031-01-01 2026-07-31
minor Completion pushed: 2029-10-01 -> 2031-06-01 2026-07-31
Trial Details
NCT Number NCT05329350
Lead Sponsor Occlutech International AB
Conditions Muscular Ventricular Septal Defect
Enrollment 50 participants
Start Date 2022-03-03
Primary Completion 2031-01-01 (estimated)
Study Completion 2031-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-30