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New registry tests device to seal dangerous heart valve leaks

NCT ID NCT07037446

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 1 time

Summary

This study follows up to 200 people who receive a special device to close leaks that can form around previously implanted heart valves. The leak can cause heart failure or destroy red blood cells. The device is placed using a thin tube through a blood vessel, avoiding open-heart surgery. Researchers will monitor safety and how well the device works for up to 3 years.

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 200 people

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

Started

Feb 2025

Expected to finish

Dec 2030

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

The Occlutech® PLD is indicated for patients with a significant leak that causes hemodynamically significant heart failure or hemolysis which requires recurrent blood transfusions. It is further indicated for patients who are deemed at high risk for surgery after consultation with the surgeon or as an alternative to surgery with less operational time and recovery period. The investigation population matches the target population.

Ages

18 years and older

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: • Patient meeting the indication and area of application of the PLD device as laid down in the IFU. The Occlutech® PLD is indicated for patients with a significant leak that causes hemodynamically significant heart failure or hemolysis which requires recurrent blood transfusions. It is further indicated for patients who are deemed at high risk for surgery after consultation with the surgeon or as an alternative to surgery with less operational time and recovery period. * Male of female patients * Patients of age ≥ 18 years * Patients understanding the nature of the study and providing their informed consent to participation. * Patients willing and able to attend the follow-up visits and procedures foreseen by study CIP. Exclusion Criteria: * Contraindications as described in the IFU: * Acute infection or any serious infection 1 month prior to procedure * Adequate oral anti-coagulation therapy / platelet inhibition is not possible post-intervention. * Allergies to nickel and/or titanium and/or nickel/titanium-based materials * Intolerance to contrast agents * Known coagulation disorder * Known intra-cardiac thrombus * Recent pelvic venous thrombosis * Recent myocardial infarction or a surgical bypass operation in the last 30 days Note: a positive result to a pregnancy test necessitates the exclusion of the subject from the registry.

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Conditions

The condition(s) this trial relates to.

periventricular leukomalacia

As listed by the trial registrant

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

Paravalvular leak Paravalvular leak device (PLD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

  • Deutsches Herzzentrum der Charité in Berlin

    Berlin, Germany

  • Gottsegen National Cardiovascular Center

    Budapest, Hungary

  • Gülhane Eğitim Araştırma Hastanesi

    Ankara, Keçiören, 06010, Turkey (Türkiye)

  • Hacettepe Üniversitesi

    Ankara, Turkey (Türkiye)

  • Hippokration Hospital

    Athens, Greece

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Spain

  • Hôpital Européen

    Marseille, France

  • Hôpital Marie Lannelongue (Paris)

    Paris, France

  • Interbalkan European Medical Center, Heart Center Thessaloniki

    Thessaloniki, Greece

  • Kocaeli Üniversitesi Hastanesi

    Kocaeli, Turkey (Türkiye)

  • Medical School of the University

    Szeged, Hungary

  • Medical University of Silesia

    Katowice, France

  • Mehmet Akif Ersoy GKDC Eğitim Araştırma Hastanesi

    Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

  • SBÜ Bursa Yüksek İhtisas Eğitim ve Araştırma Hastanesi

    Bursa, Yıldırım, 16310, Turkey (Türkiye)

  • SBÜ Etlik Şehir Hastanesi Göğüs Kalp ve Damar Hastalıkları

    Ankara, Yenimahalle, 06170, Turkey (Türkiye)

  • Sotiria Hospital

    Athens, Greece

  • Tekirdağ Namık Kemal Üniversitesi Hastanesi

    Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

  • University Hospital Dresden

    Dresden, Germany

  • University Hospital Munich

    München, Germany

  • À l'Infirmerie Protestante de Lyon

    Lyon, France

  • Özel Ankara Güven Hastanesi

    Ankara, Çankaya, 06540, Turkey (Türkiye)

  • İzmir Bayraklı Şehir Hastanesi

    Izmir, Bayraklı, 35540, Turkey (Türkiye)