Follows people with heart failure who received an atrial flow regulator device
Follows heart failure patients treated with the Occlutech atrial flow regulator device over time.
Plain-language title generated from the registry record
Registry title: The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
Key facts
- Where
- Besançon, Bourdeaux, Lyon, Montpellier, and Toulouse, FranceSee the 5 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting heart failure with symptoms who may receive the Occlutech Atrial Flow Regulator device, so its safety and effect can be followed.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Long-lasting heart failure with symptoms (NYHA class 2 or higher). Pressure in the left upper heart chamber must be at least 5 mmHg higher than in the right. LVEF must be 15% or more.
- Earlier treatment
- Stable standard heart failure treatment for at least 1 month before consent.
- Biomarker or test result
- If LVEF is above 40%, NT-pro-BNP must be raised: 125 pg/mL or more, or 365 pg/ml or more with atrial fibrillation.
Main reasons for not taking part
- Life expectancy under 1 year, advanced (stage D) heart failure, or waiting for a heart transplant
- Signs of right heart failure or severe pulmonary hypertension
- Uncontrolled high blood pressure or uncontrolled atrial fibrillation
- Stroke, blood clot or heart attack in the recent past
- Kidney disease that needs dialysis
Read by machine on 12 November 2026.
Where in France
- CHU BesançonBesançon, FranceContact: Gönül Sonmez UtkunTaking people
- CHU BourdeauxBourdeaux, FranceContact: Gönül Sonmez UtkunTaking people
- Chu LyonLyon, FranceContact: Gönül Sonmez UtkunTaking people
- CHU MontpellierMontpellier, FranceContact: Gönül Sonmez UtkunTaking people
- Centre Hospitalier Universitaire RangueilToulouse, FranceContact: Gönül Sonmez UtkunNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Occlutech International AB
- Trial code
- NCT04405583
- Record updated
- 8 June 2026
- Original description
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device; Prior diagnosis of primary pulmonary hypertension; 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; Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment; 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); 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; Clinically significant valvular heart disease:; regurgitation grade ≥3+ or; severe stenosis of mitral or tricuspid valves, or; significant stenosis of aortic valves; Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration; Clinically significant coagulation disorder, at discretion of investigator; Chronic kidney disease currently requiring dialysis; Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if not medically manageable; 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); Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy; Echocardiographic evidence of intra-cardia mass, thrombus or vegetation; 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; ICD or right sided pacemaker placement within 2 months; Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator.