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The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 1 year following implantation |
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Inclusion Criteria:
Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum
Exclusion Criteria:
Occlutech® PmVSD Occluder is contraindicated for the following:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Health Ireland | Dublin | Ireland | ||||
| Queen Sirikit National Institute of Child Health |
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| Bangkok |
| Thailand |
| Prince of Songkla University | Hat Yai | Thailand |
| Osmangazi University Faculty of Medicine Hospital | Eskişehir | 26040 | Turkey (Türkiye) |
| Gaziantep University Hospital | Gaziantep | Turkey (Türkiye) |
| Izmir University of Health Sciences Tepecik Training and Research Hospital | Izmir | 35020 | Turkey (Türkiye) |
| Kocaeli University Research and Application Hospital | Kocaeli | 41001 | Turkey (Türkiye) |
| City Children Hospital | Ho Chi Minh City | Vietnam |