New heart implant aims to ease heart failure burden

NCT ID NCT04405583

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

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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.

HEART FAILURE

Contacts and locations

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
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
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
Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi
RECRUITING

Kocaeli, Turkey (Türkiye)
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
University Clinic Jena
RECRUITING

Jena, Germany
University Clinic Tübingen
ACTIVE_NOT_RECRUITING

Tübingen, Germany
WKK Heide
RECRUITING

Heide, Germany
İzmir City Hospital
RECRUITING

Izmir, Turkey (Türkiye)

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