An observational study in Perimembranous Ventricular Septal Defect, sponsored by Occlutech International AB. Active, not recruiting at 8 sites in 4 countries. Per ClinicalTrials.gov, last updated 2026-01-16.
Sponsored by Occlutech International AB · Observational
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Occlutech International AB is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
There will be no pre-selection of patients for enrollment in this registry. The criteria provided in the Instructions For Use should be followed. The study cohort will thus consist of consecutively enrolled patients at the discretion of the treating physician
Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum
Exclusion Criteria:
Occlutech® PmVSD Occluder is contraindicated for the following:
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary efficacy endpoint is defined as successful implantation of the device with a proper closure of the pmVSD (defined as reduction in VSD shunt of more than one grade as assessed by TTE post implantation).
Time frame: 1 year following implantation
To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
The primary safety endpoint is defined as absence of Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, complete heart block requiring pacemaker implantation or device explantation, new-onset of severe tricuspid regurgitation (TR), new onset of severe aortic regurgitation (AR), device embolization, severe right-left ventricular outflow obstruction (RVOTO-LVOTO), cardiac tamponade, infective endocarditis or vascular complications requiring surgery.
Time frame: 1 year following implantation
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Occlutech International AB