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

January 27, 2026 updated by: Occlutech International AB

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU Besançon
      • Bourdeaux, France
        • Recruiting
        • CHU Bourdeaux
      • Lyon, France
        • Recruiting
        • CHU Lyon
      • Montpellier, France
        • Recruiting
        • CHU Montpellier
      • Toulouse, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire Rangueil
  • Germany
      • Bottrop, Germany
        • Not yet recruiting
        • Knappschaftskrankenhaus Bottrop GmbH
        • Principal Investigator:
          • Martin Christ, MD
      • Coburg, Germany
        • Recruiting
        • Clinic Coburg
        • Contact:
        • Principal Investigator:
          • Steffen Schnupp
      • Cologne, Germany
        • Recruiting
        • University Clinic
        • Principal Investigator:
          • Roman Pfister
      • Erfurt, Germany
        • Active, not recruiting
        • Helios Clinic Erfurt
      • Hamburg, Germany
        • Terminated
        • Cardiologicum Hamburg
      • Heide, Germany
        • Recruiting
        • WKK Heide
        • Contact:
        • Principal Investigator:
          • Patrik Diemert
      • Jena, Germany
        • Recruiting
        • University Clinic Jena
        • Contact:
          • Sven Möbius-Winkler
          • Phone Number: +4936419324503
        • Principal Investigator:
          • Sven Möbius-Winkler
      • Osnabrück, Germany
        • Recruiting
        • Hospital Osnabrueck
        • Contact:
        • Principal Investigator:
          • Mathias Lange
      • Stade, Germany
      • Tübingen, Germany
        • Active, not recruiting
        • University Clinic Tübingen
  • Greece
      • Athens, Greece
        • Recruiting
        • Hippokration Hospital Athens
      • Athens, Greece
        • Not yet recruiting
        • Mitera Hospital Athens
      • Athens, Greece
        • Not yet recruiting
        • Onassis Cardiac Surgery Center
      • Thessaloniki, Greece
        • Recruiting
        • European Interbalkan Medical Center
      • Thessaloniki, Greece
        • Recruiting
        • Hippokration Hospital of Thessaloniki
  • Italy
      • Florence, Italy
        • Not yet recruiting
        • Careggi University Hospital
      • Milan, Italy
        • Recruiting
        • Centro Cardiologico Monzino
  • Portugal
      • Carnaxide, Portugal
        • Not yet recruiting
        • Hospital de Santa Cruz
      • Lisbon, Portugal
        • Not yet recruiting
        • Hospital de Santa Marta
  • Serbia
      • Dedinje, Serbia
        • Not yet recruiting
        • Dedinje Cardiovascular Institute
  • Tunisia
      • Tunis, Tunisia
        • Recruiting
        • Rabta Hospital
      • Tunis, Tunisia
        • Recruiting
        • The Military Hospital of Tunis
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara Etlik Sehir Hastanesi
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Guven Hospital
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Hacettepe Universitesi Tip Fakultesi
      • Elâzığ, Turkey (Türkiye)
        • Recruiting
        • Firat University Hospital
      • Erzincan, Turkey (Türkiye)
        • Recruiting
        • Binali Yildirim University Mengücek Gazi Training and Resear
      • Fatih, Turkey (Türkiye)
        • Recruiting
        • Bezmialem Uni. Hospital
      • Izmir, Turkey (Türkiye)
        • Recruiting
        • Izmir City Hospital
      • Kocaeli, Turkey (Türkiye)
        • Recruiting
        • Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
      • Tekirdağ, Turkey (Türkiye)
        • Recruiting
        • Namik Kemal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of subjects with at least one Major Adverse Cardiovascular and Neurologic Events (MACNE) in the 1 year following implantation.
Time Frame: 1 year
MACNE includes all-cause mortality, stroke, systemic thromboembolism, open cardiac surgery or major endovascular repair, and major bleeding (BARC 3-5).
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of subjects with at least one SAE/ (S)ADE at 12 months, 24 months and 36 months after implantation.
Time Frame: 3 years
3 years
Cardiovascular Events at 12 months, 24 months and 36 months after implantation.
Time Frame: 3 years
Heart Failure hospitalization rate; Cardiovascular mortality; Unplanned HF admission or treatment intensification.
3 years
Device performance at 12 months, 24 months and 36 months after implantation.
Time Frame: 3 years
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.
3 years
NYHA class status in comparison to Baseline.
Time Frame: 3 years
3 years
Subject QoL assessment using the KCCQ in comparison to Baseline.
Time Frame: 3 years
3 years
6 Minute Walk Test distance [m] in comparison to Baseline.
Time Frame: 3 years
3 years
Heart rhythm in comparison to Baseline
Time Frame: 3 years
3 years
Left Ventricular (LV), Right Ventricular (RV) and Left Atrial (LA) structure and function including strain derived indices in comparison to Baseline.
Time Frame: 3 years
3 years
Left Ventricular Ejection Fraction (LVEF) in comparison to Baseline.
Time Frame: 3 years
3 years
Tricuspid Annular Plane Systolic Excursion (TAPSE) in comparison to Baseline.
Time Frame: 3 years
3 years
Laboratory variables
Time Frame: 3 years
Laboratory variables, including changes from baseline in: eGRF, NT-Pro-BNP [pg/ml]
3 years
Changes in heart failure related medication
Time Frame: 3 years
reduction/increase of daily dose [%]
3 years
Relationship between pacemaker therapy and intra atrial shunt therapy
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 25, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Occ2020_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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