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

Key facts

Who runs it
Occlutech International AB
Where
Ireland, Türkiye, and United Kingdom6 sites in 3 countriesChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
50 people, planned
Started
3 Mar 2022
Expected to end
1 Jun 2031
Type of study
Observational
Treatments tested
  • Occlutech muscular ventricular septal defect (mVSD) Occluder
Record updated
30 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with a hole in the muscular wall between the heart's lower chambers (muscular ventricular septal defect). It must be important enough to close with the Occlutech mVSD device through a catheter.

Age
3 Months to 80 Years
Sex
Male or female
Disease stage
Muscular ventricular septal defect that matters for blood flow or symptoms, and needs closing through a catheter. The hole must be 20 mm across or smaller.
Earlier treatment
People who had a heart attack or heart bypass surgery in the last 30 days cannot join.

Main reasons for not taking part

  • Active infection, sepsis, or a serious infection in the 1 month before the procedure
  • Allergy to antiplatelet or anticoagulant (blood-thinning) medicines, or to nickel and/or titanium
  • Blood clots inside the heart seen on echocardiography (heart ultrasound)
  • Perimembranous VSD, a hole after a heart attack, an aortic rim of less than 2 mm, or wall thickness > 7 mm where the device goes
  • Cancer with life expectancy of less than 3 years

The registry criteria, word for word

Show all 26 criteriaShow less

Who can take part

  • 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
  • Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP; Contraindication
  • Hemodynamically relevant VSD shunt
  • Congestive heart insufficiency
  • Recurrent respiratory infections
  • Failure to thrive
  • Significant left ventricle (LV) enlargement
  • Significant left atrium (LA) enlargement
  • Other clinical indication

Who cannot take part

  • Any type of serious infection 1 month before the procedure
  • ⦁Active bacterial infections
  • 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
  • Malignancy where life expectancy is less than 3 years
  • Recent myocardial infarction or a surgical bypass operation in the last 30 days
  • The device is contraindicated for participants known to have any of the following:
  • The aortic rim of less than 2 mm
  • Demonstrated intracardiac thrombi on echocardiography
  • mVSD diameter > 20 mm
  • Perimembranous VSD; Post-MI VSD
  • Sepsis (local or generalized)
  • Septal thickness > 7 mm in the area of the Occluder placement

This trial has no sites in United States.

It has sites in 3 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

Read full original descriptionShow less

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.

The group in the trial

  • muscular ventricular septal defects

    patients with muscular ventricular septal defects

    Treatment: Occlutech muscular ventricular septal defect (mVSD) Occluder

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® Muscular Ventricular Septal Defect (mVSD) Occluder in Patients With Muscular Ventricular Septal Defects
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
30 July 2026
Under construction, not live – Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases (NCT05329350) – Frontlight Research