Safety and effectiveness follow-up study of a heart device for muscular heart defects

Plain-English translation of NCT05329350 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated June 2026 · How we translate trials

What is this trial?

This is a follow-up study of the Occlutech mVSD Occluder, a small device designed to close muscular ventricular septal defects—holes in the wall between the heart's lower chambers that can strain the heart. Researchers are monitoring how safe and effective this device is in real-world use by tracking patients after they receive the implant. The device is placed using a catheter procedure, avoiding open-heart surgery.

Muscular holes in the heart can force the heart to work harder and cause health problems. While surgery can repair these holes, this new treatment offers a less invasive option. This study ensures the device performs safely and effectively over time in patients who have already received it.

Do you qualify?

You likely qualify if…

you have been diagnosed with a muscular ventricular septal defect (a hole between the lower chambers of your heart)
your doctor has determined the hole is significant enough to need treatment
you are willing to attend follow-up visits over three years
you understand the study and give informed consent to participate
you are any age (from infants to adults)

You likely don't qualify if…

you have an active bacterial infection or serious infection within the last month
you are allergic to nickel, titanium, or blood-thinning medications
you have had a heart attack or heart surgery in the last 30 days
your heart defect is too large (more than 20 mm) or in a location called perimembranous
you have a serious condition (like certain cancers) where life expectancy is less than 3 years

What participation looks like

You will receive the Occlutech device through a minimally invasive catheter procedure performed by experienced heart specialists. After the procedure, you will have follow-up visits within 48 hours, at 30–60 days, at 6 months, at 1 year, and at 3 years. Each visit includes heart imaging (echocardiography), heart rhythm checks (ECGs), vital signs, and blood tests to ensure the device is working safely and effectively.

AI-generated summary from trial data · Jun 16, 2026 · Not medical advice

Trial locations(5 sites)

Ireland

Children's Health Ireland, Dublin

Turkey (Türkiye)

İzmir Şehir Hastanesi, Izmir, Bayraklı

Eskişehir Osmangazi Üniversite Hastanesi, Eskişehir, Odunpazarı

Dicle Üniversitesi Tıp Fakültesi Hastanesi, Diyarbakır, Sur

Gaziantep Unıversıty Hospital, Gaziantep, Şehitkamil