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NCT Number: NCT04034498

A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Perimembranous Ventricular Septal Defect

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Health Ireland, Dublin, Ireland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Occlutech International AB

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 26, 2019
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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