A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
Eligibility
Sex
ALL
Min age
—
Max age
—
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
Primary outcome measure(s)
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.
Trial sites (8)
Facility
City
Region
Status
Children Health Ireland
Dublin
Ireland
Queen Sirikit National Institute of Child Health
Bangkok
Thailand
Prince of Songkla University
Hat Yai
Thailand
Osmangazi University Faculty of Medicine Hospital
Eskişehir
Turkey (Türkiye)
Gaziantep University Hospital
Gaziantep
Turkey (Türkiye)
Izmir University of Health Sciences Tepecik Training and Research Hospital
Izmir
Turkey (Türkiye)
Kocaeli University Research and Application Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.