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

January 14, 2026 updated by: Occlutech International AB

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

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland
        • Children Health Ireland
  • Thailand
      • Bangkok, Thailand
        • Queen Sirikit National Institute of Child Health
      • Hat Yai, Thailand
        • Prince of Songkla University
  • Turkey (Türkiye)
      • Eskişehir, Turkey (Türkiye), 26040
        • Osmangazi University Faculty of Medicine Hospital
      • Gaziantep, Turkey (Türkiye)
        • Gaziantep University Hospital
      • Izmir, Turkey (Türkiye), 35020
        • Izmir University of Health Sciences Tepecik Training and Research Hospital
      • Kocaeli, Turkey (Türkiye), 41001
        • Kocaeli University Research and Application Hospital
  • Vietnam
      • Ho Chi Minh City, Vietnam
        • City Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To confirm the efficacy of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
Time Frame: 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).
1 year following implantation
To confirm the safety of Occlutech PmVSD in patients requiring transcatheter occlusion (closure) of perimembranous ventricular septal defects.
Time Frame: 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.
1 year following implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 18, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 26, 2019

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Occ2018-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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