New heart implant aims to ease heart failure burden

NCT ID NCT04405583

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking the safety and effectiveness of a small device called the Occlutech Atrial Flow Regulator in 150 people with chronic heart failure. The device is implanted to create a small opening between the upper chambers of the heart, which may help reduce pressure and improve symptoms. Researchers will monitor participants for up to three years for serious events like stroke or heart-related hospitalization.

What this could mean

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

Active substance

Occlutech Atrial Flow Regulator (a small implant placed in the heart to create a shunt between the upper chambers)

What this could lead to

If it works, this device could offer a new way to manage heart failure symptoms and reduce hospitalizations by easing pressure in the heart.

What could go wrong

This is a follow-up study, not a randomized trial, so results may be less definitive. The device carries risks like stroke, bleeding, or need for additional surgery.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Ankara Etlik Şehir Hastanesi

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Bezmialem Uni. Hospital

    RECRUITING

    Fatih, Turkey (Türkiye)

  • Binali Yildirim University Mengücek Gazi Training and Resear

    RECRUITING

    Erzincan, Turkey (Türkiye)

  • CHU Besançon

    RECRUITING

    Besançon, France

  • CHU Bourdeaux

    RECRUITING

    Bourdeaux, France

  • CHU Lyon

    RECRUITING

    Lyon, France

  • CHU Montpellier

    RECRUITING

    Montpellier, France

  • Cardiologicum Hamburg

    TERMINATED

    Hamburg, Germany

  • Careggi University Hospital

    NOT_YET_RECRUITING

    Florence, Italy

  • Centre Hospitalier Universitaire Rangueil

    NOT_YET_RECRUITING

    Toulouse, France

  • Centro Cardiologico Monzino

    RECRUITING

    Milan, Italy

  • Clinic Coburg

    RECRUITING

    Coburg, Germany

    Contact

  • Dedinje Cardiovascular Institute

    NOT_YET_RECRUITING

    Dedinje, Serbia

  • Elbe Clinic Stade

    RECRUITING

    Stade, Germany

  • European Interbalkan Medical Center

    RECRUITING

    Thessaloniki, Greece

  • Firat University Hospital

    RECRUITING

    Elâzığ, Turkey (Türkiye)

  • Güven Hospital

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Hacettepe Üniversitesi Tip Fakültesi

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Helios Clinic Erfurt

    ACTIVE_NOT_RECRUITING

    Erfurt, Germany

  • Hippokration Hospital Athens

    RECRUITING

    Athens, Greece

  • Hippokration Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, Greece

  • Hospital Osnabrueck

    RECRUITING

    Osnabrück, Germany

    Contact

  • Hospital de Santa Cruz

    NOT_YET_RECRUITING

    Carnaxide, Portugal

  • Hospital de Santa Marta

    NOT_YET_RECRUITING

    Lisbon, Portugal

  • Knappschaftskrankenhaus Bottrop GmbH

    NOT_YET_RECRUITING

    Bottrop, Germany

    Contact

  • Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi

    RECRUITING

    Kocaeli, Turkey (Türkiye)

    Contact

  • Mitera Hospital Athens

    NOT_YET_RECRUITING

    Athens, Greece

  • Namik Kemal University Hospital

    RECRUITING

    Tekirdağ, Turkey (Türkiye)

  • Onassis Cardiac Surgery Center

    NOT_YET_RECRUITING

    Athens, Greece

  • Rabta Hospital

    RECRUITING

    Tunis, Tunisia

  • The Military Hospital of Tunis

    RECRUITING

    Tunis, Tunisia

  • University Clinic

    RECRUITING

    Cologne, Germany

    Contact

  • University Clinic Jena

    RECRUITING

    Jena, Germany

    Contact

  • University Clinic Tübingen

    ACTIVE_NOT_RECRUITING

    Tübingen, Germany

  • WKK Heide

    RECRUITING

    Heide, Germany

    Contact

  • İzmir City Hospital

    RECRUITING

    Izmir, Turkey (Türkiye)