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New heart implant aims to ease heart failure burden

NCT ID NCT04405583

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

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

Started

Oct 2020

Expected to finish

Jun 2031

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

150 Heart Failure patients with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF), age ≥18 years, who gave their signed and dated informed consent will be included in the study analysis.

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: 1. Written, informed consent 2. Age ≥18 years 3. Presence of chronic symptomatic HF (NYHA class ≥ 2) 4. Left Atrial Pressure (LAP) \> Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\* 5. LVEF ≥ 15%. If LVEF is \>40% (HFpEF), BMI corrected\*\* NT-pro-BNP must be elevated ≥ 125 pg/mL. (BNP \>35 pg/mL) or ≥ 365pg/ml (BNP \> 105 pg/mL) for patients with atrial fibrillation (AF) 6. Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent Exclusion Criteria: 1. Life expectancy \< 1 year, or advanced heart failure defined as ACC/AHA Stage D heart failure, or listed for heart transplantation at time of baseline visit 2. Evidence of right heart failure defined (by ECHO) as: 1. Severe Right Ventricular Dysfunction (TAPSE \< 14 mm) 2. Severe Right Ventricular Dilatation (RV volume ≥ LV volume) 3. Severe pulmonary hypertension (PASP \> 60 mm Hg) 3. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation 4. Uncontrolled hypertension, Systolic Blood Pressure of \>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit. 5. Uncontrolled atrial fibrillation with resting heart rate \>110bpm, despite medical therapy 6. Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease 7. Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator. 8. Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device 9. Current atrial septal defect, or anatomical anomaly (including \> 10 mm atrial septal thickness or atrial septal aneurysm) on ECHO that precludes implantation of the device across the fossa ovalis (FO) of the interatrial septum 10. Clinically significant valvular heart disease: 1. regurgitation grade ≥3+ or 2. severe stenosis of mitral or tricuspid valves, or 3. significant stenosis of aortic valves 11. Prior diagnosis of primary pulmonary hypertension 12. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration 13. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within 6 months, or any prior stroke with persistent neurologic deficit, or any prior intracranial bleed, or known intracerebral aneurysm, AV malformation or other intracranial pathology increasing the risk of bleeding 14. Myocardial Infarction (MI) and/or coronary heart disease with indication for a coronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 months prior to informed consent. 15. ICD or right sided pacemaker placement within 2 months 16. Clinically significant coagulation disorder, at discretion of investigator 17. Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment 18. Chronic kidney disease currently requiring dialysis 19. Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable 20. Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy 21. Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator 22. Other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator Note: \* LA pressure is substituted by PCW at the right heart catheterization measure while patient is awaken \*\*"Corrected" refers to a 4% reduction in the NT-proBNP cutoff for every increase of 1kg/m2 in body mass index (BMI) above a reference BMI of 20kg/m2)

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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

How to take part

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

  1. The places running it

    33 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • 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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