New heart device aims to patch holes without surgery
NCT ID NCT05329350
First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This study is testing a device called the Occlutech mVSD Occluder to close a type of hole in the heart (muscular ventricular septal defect) without open surgery. The device is inserted through a blood vessel in the leg and guided to the heart. Researchers will follow 50 patients for one year to see if the device safely closes the hole and reduces blood flow problems. The goal is to offer a less invasive treatment option for people with this heart condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Occlutech muscular ventricular septal defect (mVSD) occluder (a self-expanding mesh device implanted via catheter to close a hole in the heart)
- What this could lead to
- If successful, this device could offer a less invasive, non-surgical option to close muscular ventricular septal defects, potentially reducing recovery time and surgical risks.
- What could go wrong
- This is a small, early-stage follow-up study with only 50 participants. The device may cause serious complications like stroke, heart block, or device movement. Long-term benefits and risks are not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Jun 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male and female patients of any age with a hemodynamically or clinically significant muscular ventricular septal defect (mVSD) who are candidates for non-surgical closure with the Occlutech mVSD Occluder in routine clinical practice (predominantly pediatric patients). Eligibility is confirmed based on protocol-defined inclusion/exclusion criteria and baseline clinical assessment, including medical history, demographics, vital signs, ECG and echocardiography; laboratory tests may be performed according to local standard of care.
- Ages
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3 months to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * 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 Exclusion Criteria The device is contraindicated for participants known to have any of the following: ⦁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 * Any type of serious infection 1 month before the procedure * The aortic rim of less than 2 mm * Demonstrated intracardiac thrombi on echocardiography * Malignancy where life expectancy is less than 3 years * mVSD diameter \> 20 mm * Perimembranous VSD Post-MI VSD * Recent myocardial infarction or a surgical bypass operation in the last 30 days * Sepsis (local or generalized) * Septal thickness \> 7 mm in the area of the Occluder placement
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Health Ireland
NOT_YET_RECRUITINGDublin, N512, Ireland
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Dicle Üniversitesi Tıp Fakültesi Hastanesi
NOT_YET_RECRUITINGDiyarbakır, Sur, Turkey (Türkiye)
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Eskişehir Osmangazi Üniversite Hastanesi
NOT_YET_RECRUITINGEskişehir, Odunpazarı, 26040, Turkey (Türkiye)
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Gaziantep Unıversıty Hospital
RECRUITINGGaziantep, Şehitkamil, 27310, Turkey (Türkiye)
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Royal Brompton Hospital
NOT_YET_RECRUITINGLondon, England, SW3 6NP, United Kingdom
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İzmir Şehir Hastanesi
NOT_YET_RECRUITINGIzmir, Bayraklı, 35540, Turkey (Türkiye)
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