Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-80
SponsorOcclutech International AB

About this trial

The Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.

The objectives of the study are:

* To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects. * To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.

Eligibility criteria

Qualifiers

A participant will be eligible for study participation if he/she meets the indication and area of application as laid down in the IFU. The Occlutech mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects.

Any age

Male or female.

Patients understand the nature of the study and provide their informed consent to participation.

Disqualifiers

Active infection at the time of implantation

Allergy to antiplatelet or anticoagulant therapy

Allergy to nickel and/or titanium and/or nickel/titanium-based materials

Any type of serious infection 1 month before the procedure

Trial design

Treatments tested in this trial

  • Occlutech muscular ventricular septal defect (mVSD) Occluder

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators