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

NCT04034498 | Active Not Recruiting

• 1 other identifier: Occ2018-01
• Study Type: observational
• Target: 50
• Locations: 4 countries
• Sites: 8

Brief Summary

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

Conditions

Perimembranous Ventricular Septal Defect

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum

You may not qualify if:

• 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

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (8)

Children Health Ireland

Dublin, Ireland

Location

Queen Sirikit National Institute of Child Health

Bangkok, Thailand

Location

Prince of Songkla University

Hat Yai, Thailand

Location

Osmangazi University Faculty of Medicine Hospital

Eskişehir, 26040, Turkey (Türkiye)

Location

Gaziantep University Hospital

Gaziantep, Turkey (Türkiye)

Location

Izmir University of Health Sciences Tepecik Training and Research Hospital

Izmir, 35020, Turkey (Türkiye)

Location

Kocaeli University Research and Application Hospital

Kocaeli, 41001, Turkey (Türkiye)

Location

City Children Hospital

Ho Chi Minh City, Vietnam

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 26, 2019
• Study Start: July 7, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4); IE (1); VN (1); TH (2)