Occlutech mVSD for Muscular Ventricular Septal Defect

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

Recruiting Observational Study
Muscular Ventricular Septal Defect
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
3 Months – 80
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Occlutech International AB · Industry
Who this trial is looking for

This trial is looking for patients needing treatment for muscular ventricular septal defects. Participants will receive the Occlutech mVSD device and will need to attend follow-up visits.

Are You a Good Fit for This Trial?
Rules you out Active bacterial infectionsSepsisRecent myocardial infarction

You may be able to join if

  • I have a muscular ventricular septal defect.
  • I am any age.
  • I am male or female.
  • I understand the study and agree to participate.
  • I can attend follow-up visits.

You may not be able to join if

  • I have a serious bacterial infection.
  • I have had a heart attack or bypass surgery in the last 30 days.
  • I have significant issues with my heart size.
  • I have an allergy to certain metal materials.
  • I have a diameter of VSD greater than 20 mm.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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 occlu…
Trial Locations
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Eligibility Criteria
Inclusion Criteria * 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. * …
Contacts

Ahmed Dellaa

+49 151 14139961

ahmed.dellaa@occlutech.com

CONTACT