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

Active, not recruiting

• Conditions: Perimembranous Ventricular Septal Defect

• Registration Number: NCT04034498
• Lead Sponsor: Occlutech International AB

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-07
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-25
• Study First Posted: 2019-07-26
• Status Verified: 2023-12
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15
• Primary Completion: 2026-06
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (5)

Ludwig Maximilians University; 🇩🇪 Munich, Germany

City Children Hospital; 🇻🇳 Ho Chi Minh City, Vietnam

Prince of Songkla University; 🇹🇭 Hat Yai, Thailand

Children Health Ireland; 🇮🇪 Dublin, Ireland

Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand