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Heart FailureAFR RegistryNCT04405583

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

An observational study of Heart Failure, run by Occlutech International AB at 36 sites in 8 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Occlutech Atrial Flow Regulator
Type of treatment
Medical device
How many people
150 participants
Where
36 sitesin 8 countries
Study dates
28 Oct 2020to Jun 2031
How long will I take part?
3 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Written, informed consent
  • Age ≥18 years
  • Presence of chronic symptomatic HF (NYHA class ≥ 2)
  • Left Atrial Pressure (LAP) > Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg*
  • 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)
  • Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent

Who cannot join

  • 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
  • Evidence of right heart failure defined (by ECHO) as:
  • Severe Right Ventricular Dysfunction (TAPSE < 14 mm)
  • Severe Right Ventricular Dilatation (RV volume ≥ LV volume)
  • Severe pulmonary hypertension (PASP > 60 mm Hg)
  • Echocardiographic evidence of intra-cardia mass, thrombus or vegetation
Show all 30Show fewer
  • Uncontrolled hypertension, Systolic Blood Pressure of >160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.
  • Uncontrolled atrial fibrillation with resting heart rate >110bpm, despite medical therapy
  • Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease
  • Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator.
  • Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device
  • 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
  • Clinically significant valvular heart disease:
  • regurgitation grade ≥3+ or
  • severe stenosis of mitral or tricuspid valves, or
  • significant stenosis of aortic valves
  • Prior diagnosis of primary pulmonary hypertension
  • Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration
  • 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
  • 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.
  • ICD or right sided pacemaker placement within 2 months
  • Clinically significant coagulation disorder, at discretion of investigator
  • Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment
  • Chronic kidney disease currently requiring dialysis
  • Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable
  • Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy
  • Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator
  • 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)

Trial locations and contacts

36 sites in 8 countries. Contact the study team or a site near you to ask about taking part.

Gönül Sonmez Utkun contact

+90 542 826 11 95

dl_occlutech_clinical_team_eu-ist@occlutech.com

Sankoung Minte contact

+337 68 20 44 58

sankoung.minte@keena-lifesciences.com

36 sites in 8 countries

Germany10 sites, 7 recruiting

  • Knappschaftskrankenhaus Bottrop GmbH

    Bottrop

    Martin Christ, MD

    Not yet recruiting

  • Clinic Coburg

    Coburg

    Steffen Schnupp

    Recruiting

  • University Clinic

    Cologne

    Roman Pfister

    Recruiting

  • Helios Clinic Erfurt

    Erfurt

    Active, not recruiting

  • Cardiologicum Hamburg

    Hamburg

    Terminated

  • WKK Heide

    Heide

    Patrik Diemert

    Recruiting

  • University Clinic Jena

    Jena

    Sven Möbius-Winkler

    Recruiting

  • Hospital Osnabrueck

    Osnabrück

    Mathias Lange

    Recruiting

  • Elbe Clinic Stade

    Stade

    Recruiting

  • University Clinic Tübingen

    Tübingen

    Active, not recruiting

Other trials in Germany

Turkey (Türkiye)9 sites, 9 recruiting

  • Ankara Etlik Şehir Hastanesi

    Ankara

    Recruiting

  • Güven Hospital

    Ankara

    Recruiting

  • Hacettepe Üniversitesi Tip Fakültesi

    Ankara

    Recruiting

  • Firat University Hospital

    Elâzığ

    Recruiting

  • Binali Yildirim University Mengücek Gazi Training and Resear

    Erzincan

    Recruiting

  • Bezmialem Uni. Hospital

    Fatih

    Recruiting

  • İzmir City Hospital

    Izmir

    Recruiting

  • Kocaeli Üniversitesi Araştirma Ve Uygulama Hastanesi

    Kocaeli

    Teoman Kılıç, Prof. Dr.

    Recruiting

  • Namik Kemal University Hospital

    Tekirdağ

    Recruiting

Other trials in Turkey (Türkiye)

France5 sites, 5 recruiting

  • CHU Besançon

    Besançon

    Recruiting

  • CHU Bourdeaux

    Bourdeaux

    Recruiting

  • CHU Lyon

    Lyon

    Recruiting

  • CHU Montpellier

    Montpellier

    Recruiting

  • Centre Hospitalier Universitaire Rangueil

    Toulouse

    Not yet recruiting

Other trials in France

Greece5 sites, 5 recruiting

  • Hippokration Hospital Athens

    Athens

    Recruiting

  • Mitera Hospital Athens

    Athens

    Not yet recruiting

  • Onassis Cardiac Surgery Center

    Athens

    Not yet recruiting

  • European Interbalkan Medical Center

    Thessaloniki

    Recruiting

  • Hippokration Hospital of Thessaloniki

    Thessaloniki

    Recruiting

Other trials in Greece

Italy2 sites, 2 recruiting

  • Careggi University Hospital

    Florence

    Not yet recruiting

  • Centro Cardiologico Monzino

    Milan

    Recruiting

Other trials in Italy

Portugal2 sites, 2 recruiting

  • Hospital de Santa Cruz

    Carnaxide

    Not yet recruiting

  • Hospital de Santa Marta

    Lisbon

    Not yet recruiting

Other trials in Portugal

Tunisia2 sites, 2 recruiting

  • Rabta Hospital

    Tunis

    Recruiting

  • The Military Hospital of Tunis

    Tunis

    Recruiting

Other trials in Tunisia

Serbia1 site, 1 recruiting

  • Dedinje Cardiovascular Institute

    Dedinje

    Not yet recruiting

Other trials in Serbia

About this study

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

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

Read the detailed description

This is a prospective, multicentre, international, follow-up registry to monitor the safety and the performance of the Occlutech AFR device in patients with Heart Failure, to identify unknown side effects and to assess the indications and contraindications for an AFR treatment. Efficacy and safety of implanted device(s) will be evaluated by vital signs, laboratory test, quality of life questionnaire, ECG, and echocardiography data over a follow-up period of 36 month after implantation.

Patients will be treated according to the instruction-for-use of the device and according to clinical routine. Procedures will be performed at sites having appropriate laboratory support and adequately trained imaging personnel. Procedures will be performed by physicians with experience in a wide range of interventional cardiology and structural heart disease.

Conditions
Heart Failure
Being tested
Occlutech Atrial Flow Regulator
Keywords
Occlutech AFR, Atrial Flow Regulator, Interatrial shunt device, Heart failure, HFrEF, HFpEF, Left-to-right shunt, Balloon atrial septostomy, MACNE, Device embolization, AFR, AFR Registry
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Occlutech Atrial Flow RegulatorDevice

    Also called Occlutech AFR

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation.

    MACNE includes all-cause mortality, stroke, systemic thromboembolism, open cardiac surgery or major endovascular repair, and major bleeding (BARC 3-5).

    Measured: 1 year

Secondary outcomes (13)

  1. Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation.

    Measured: 3 years

  2. Cardiovascular Events at 12 months, 24 months and 36 months after implantation.

    Heart Failure hospitalization rate; Cardiovascular mortality; Unplanned HF admission or treatment intensification.

    Measured: 3 years

  3. Device performance at 12 months, 24 months and 36 months after implantation.

    Device placed in situ as assessed by the investigator; Patency: evidence of LEFT TO RIGHT shunt through the AFR device; Implant embolization and clinically significant device migration.

    Measured: 3 years

  4. NYHA class status in comparison to Baseline.

    Measured: 3 years

  5. Subject QoL assessment using the KCCQ in comparison to Baseline.

    Measured: 3 years

  6. 6 Minute Walk Test distance [m] in comparison to Baseline.

    Measured: 3 years

  7. Heart rhythm in comparison to Baseline

    Measured: 3 years

  8. Left Ventricular (LV), Right Ventricular (RV) and Left Atrial (LA) structure and function including strain derived indices in comparison to Baseline.

    Measured: 3 years

  9. Left Ventricular Ejection Fraction (LVEF) in comparison to Baseline.

    Measured: 3 years

  10. Tricuspid Annular Plane Systolic Excursion (TAPSE) in comparison to Baseline.

    Measured: 3 years

  11. Laboratory variables

    Laboratory variables, including changes from baseline in: eGRF, NT-Pro-BNP [pg/ml]

    Measured: 3 years

  12. Changes in heart failure related medication

    reduction/increase of daily dose [%]

    Measured: 3 years

  13. Relationship between pacemaker therapy and intra atrial shunt therapy

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2020
  2. Study start28 Oct 2020
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completionJun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04405583
Sponsor's protocol ID
Occ2020_01
Acronym
AFR Registry
Status last verified
Jan 2026
First submitted
25 May 2020
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Occlutech International AB at 36 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in Germany, Turkey (Türkiye), France, Greece, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gönül Sonmez Utkun (+90 542 826 11 95, dl_occlutech_clinical_team_eu-ist@occlutech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04405583.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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