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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2026
  • participants needed
    200
  • sponsor
    Occlutech International AB
Updated on 27 January 2021

Summary

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

Details
Condition Perimembranous Ventricular Septal Defect
Clinical Study IdentifierNCT04034498
SponsorOcclutech International AB
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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