A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® PmVSD Occluder in Patients With Perimembranous Ventricular Septal Defects

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04034498
• Other study ID #: Occ2018-01
• Status: Active, not recruiting
• Start date: July 7, 2019
• Est. completion date: July 2026

Study information

• Verified date: December 2023
• Source: Occlutech International AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The objective of this registry is to gain more insight on the clinical use of the Occlutech perimembranous VSD occluder.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Perimembranous Ventricular Septal Defect

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Occlutech International AB

Countries where clinical trial is conducted

Germany,  Ireland,  Thailand,  Vietnam, 

Outcome

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