Perimembranous Ventricular Septal Defect
Conditions
Brief summary
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Interventions
None listed
Sponsors
Occlutech International AB
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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: * Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves * Patients less than 10.0 kg * Patients with sepsis (local or generalized) * Patients with left ventricle to right atrial shunting * Patients with right to left shunting through the defect * Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device * Patients with complex heart lesions such as tetralogy of fallot * History of repeated pulmonary infection * Any type of serious infection 1 month prior to procedure * Malignancy where life expectancy is less than 3 years * Demonstrated intracardiac thrombi on echocardiography * Patients with allergy to anti-platelet or anticoagulant therapy * Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials * Patients with intolerance to contrast agents * Patients with active bacterial infections * Patients with very small vessels which are not suitable for recommended delivery sheath sizes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects. | 1 year following implantation | 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). |
| To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects. | 1 year following implantation | 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. |
Countries
Ireland, Thailand, Turkey (Türkiye), Vietnam
Outcome results
None listed