RecruitingNCT04405583

The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients

A Multicentre, International, Follow-up Study to Monitor the Efficacy and Safety of the Occlutech Atrial Flow Regulator in Heart Failure Patients

Sponsor

Occlutech International AB

Enrollment

150 participants

Start Date

Oct 28, 2020

Study Type

OBSERVATIONAL

Conditions

Heart Failure

Summary

This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry follows patients with heart failure who have had a small device implanted to reduce pressure between the heart's chambers (an atrial flow regulator, or AFR). The study tracks how well the device works and monitors for any safety issues over time. **You may be eligible if...** - You are 18 or older - You have chronic heart failure with ongoing symptoms (shortness of breath at rest or with mild activity) - The left side of your heart has higher pressure than the right (confirmed by measurements) - Your heart pumps at least 15% of its capacity (LVEF ≥ 15%) - You have been on stable, guideline-recommended heart failure treatment for at least 1 month **You may NOT be eligible if...** - Your life expectancy is less than 1 year or your heart failure is at the most advanced stage - You have severe right heart failure or severely elevated lung pressure - You have a blood clot or mass inside your heart - Your blood pressure or heart rate is uncontrolled despite medication - You have a specific type of heart muscle disease such as hypertrophic or restrictive cardiomyopathy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOcclutech Atrial Flow Regulator

The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.

Locations(36)

CHU Besançon

Besançon, France

CHU Bourdeaux

Bourdeaux, France

CHU Lyon

Lyon, France

CHU Montpellier

Montpellier, France

Centre Hospitalier Universitaire Rangueil

Toulouse, France

Knappschaftskrankenhaus Bottrop GmbH

Bottrop, Germany

Clinic Coburg

Coburg, Germany

University Clinic

Cologne, Germany

Helios Clinic Erfurt

Erfurt, Germany

Cardiologicum Hamburg

Hamburg, Germany

WKK Heide

Heide, Germany

University Clinic Jena

Jena, Germany

Hospital Osnabrueck

Osnabrück, Germany

Elbe Clinic Stade

Stade, Germany

University Clinic Tübingen

Tübingen, Germany

Hippokration Hospital Athens

Athens, Greece

Mitera Hospital Athens

Athens, Greece

Onassis Cardiac Surgery Center

Athens, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Hippokration Hospital of Thessaloniki

Thessaloniki, Greece

Careggi University Hospital

Florence, Italy

Centro Cardiologico Monzino

Milan, Italy

Hospital de Santa Cruz

Carnaxide, Portugal

Hospital de Santa Marta

Lisbon, Portugal

Dedinje Cardiovascular Institute

Dedinje, Serbia

Rabta Hospital

Tunis, Tunisia

The Military Hospital of Tunis

Tunis, Tunisia

Ankara Etlik Şehir Hastanesi

Ankara, Turkey (Türkiye)

Güven Hospital

Ankara, Turkey (Türkiye)

Hacettepe Üniversitesi Tip Fakültesi

Ankara, Turkey (Türkiye)

Firat University Hospital

Elâzığ, Turkey (Türkiye)

Binali Yildirim University Mengücek Gazi Training and Resear

Erzincan, Turkey (Türkiye)

Bezmialem Uni. Hospital

Fatih, Turkey (Türkiye)

İzmir City Hospital

Izmir, Turkey (Türkiye)

Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi

Kocaeli, Turkey (Türkiye)

Namik Kemal University Hospital

Tekirdağ, Turkey (Türkiye)

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