Perimembranous Ventricular Septal Defect Clinical Trial
Official title:
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Perimembranous Ventricular Septal Defect (PmVSD) Occluder in Patients With Perimembranous Ventricular Septal Defects
| Verified date | December 2023 |
| Source | Occlutech International AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | July 2026 |
| Est. primary completion date | June 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Ludwig Maximilians University | Munich | |
| Ireland | Children Health Ireland | Dublin | |
| Thailand | Queen Sirikit National Institute of Child Health | Bangkok | |
| Thailand | Prince of Songkla University | Hat Yai | |
| Vietnam | City Children Hospital | Ho Chi Minh City |
| Lead Sponsor | Collaborator |
|---|---|
| Occlutech International AB |
Germany, Ireland, Thailand, Vietnam,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02644330 -
Minimally Invasive Transthoracic Device Closure in Perimembranous Ventricular Septal Defect
|
Phase 2/Phase 3 |