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Heart hole device under the microscope: does it hold up?

NCT ID NCT04034498

Disease control Sponsor: Occlutech International AB Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 50 people who have a hole in the wall between their heart's lower chambers (a perimembranous VSD). They received a special device to close the hole without open-heart surgery. Researchers are checking if the device stays in place and closes the hole properly, and if there are any serious side effects like heart block or infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Occlutech perimembranous VSD occluder (a device to close a hole in the heart)
What this could lead to
If successful, this could confirm that the device is a safe and effective way to close certain heart holes without open-heart surgery.
What could go wrong
This is a follow-up study with only 50 participants, so results may not apply to everyone. Risks include serious complications like heart block or device problems.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2019

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

There will be no pre-selection of patients for enrollment in this registry. The criteria provided in the Instructions For Use should be followed. The study cohort will thus consist of consecutively enrolled patients at the discretion of the treating physician

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients with haemodynamically significant perimembranous defects which are located in the ventricular septum Exclusion Criteria: Occlutech® PmVSD Occluder is contraindicated for the following: * Patients with defects less than 2 mm aortic rim and/or interference with the aortic or atrioventricular valves * Patients less than 10.0 kg * Patients with sepsis (local or generalized) * Patients with left ventricle to right atrial shunting * Patients with right to left shunting through the defect * Patients with PmVSD with an aneurysm and multiple shunts that could not be successfully closed with one device * Patients with complex heart lesions such as tetralogy of fallot * History of repeated pulmonary infection * Any type of serious infection 1 month prior to procedure * Malignancy where life expectancy is less than 3 years * Demonstrated intracardiac thrombi on echocardiography * Patients with allergy to anti-platelet or anticoagulant therapy * Patients with allergy to nickel and/or titanium and/or nickel/titanium based materials * Patients with intolerance to contrast agents * Patients with active bacterial infections * Patients with very small vessels which are not suitable for recommended delivery sheath sizes

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Conditions

The condition(s) this trial relates to.

ventricular septal defect

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Perimembranous ventricular septal defect

Contacts and locations

Locations

  • Children Health Ireland

    Dublin, Ireland

  • City Children Hospital

    Ho Chi Minh City, Vietnam

  • Gaziantep University Hospital

    Gaziantep, Turkey (Türkiye)

  • Izmir University of Health Sciences Tepecik Training and Research Hospital

    Izmir, 35020, Turkey (Türkiye)

  • Kocaeli University Research and Application Hospital

    Kocaeli, 41001, Turkey (Türkiye)

  • Osmangazi University Faculty of Medicine Hospital

    Eskişehir, 26040, Turkey (Türkiye)

  • Prince of Songkla University

    Hat Yai, Thailand

  • Queen Sirikit National Institute of Child Health

    Bangkok, Thailand

More trials for these conditions

Other studies related to the condition(s) this trial covers.