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Written, informed consent\n2. Age ≥18 years\n3. Presence of chronic symptomatic HF (NYHA class ≥ 2)\n4. Left Atrial Pressure (LAP) \\> Right Atrial Pressure (RAP); with a gradient equal or more than 5 mmHg\\*\n5. LVEF ≥ 15%. If LVEF is \\>40% (HFpEF), BMI corrected\\*\\* NT-pro-BNP must be elevated ≥ 125 pg\u002FmL. (BNP \\>35 pg\u002FmL) or ≥ 365pg\u002Fml (BNP \\> 105 pg\u002FmL) for patients with atrial fibrillation (AF)\n6. Stable guideline directed treatment according to latest applicable ESC guidelines for respective HF phenotypes for at least 1 months prior to informed consent\n\nExclusion Criteria:\n\n1. Life expectancy \\\u003C 1 year, or advanced heart failure defined as ACC\u002FAHA Stage D heart failure, or listed for heart transplantation at time of baseline visit\n2. Evidence of right heart failure defined (by ECHO) as:\n\n   1. Severe Right Ventricular Dysfunction (TAPSE \\\u003C 14 mm)\n   2. Severe Right Ventricular Dilatation (RV volume ≥ LV volume)\n   3. Severe pulmonary hypertension (PASP \\> 60 mm Hg)\n3. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation\n4. Uncontrolled hypertension, Systolic Blood Pressure of \\>160 mmHg or Diastolic Blood Pressure ≥ 100mmHg, despite medical therapy at the time of screening visit.\n5. Uncontrolled atrial fibrillation with resting heart rate \\>110bpm, despite medical therapy\n6. Documented history of specific cardiomyopathy (obstructive hypertrophic, restrictive, infiltrative) or pericardial disease\n7. Congenital heart defect that interferes with placement of the device, at the discretion of the Investigator.\n8. Previous interventional or surgical atrial septal defect (ASD) or patent foramen ovale (PFO) closure interfering with the placement of the device\n9. 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\n10. Clinically significant valvular heart disease:\n\n    1. regurgitation grade ≥3+ or\n    2. severe stenosis of mitral or tricuspid valves, or\n    3. significant stenosis of aortic valves\n11. Prior diagnosis of primary pulmonary hypertension\n12. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapy or oxygen administration\n13. 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\n14. Myocardial Infarction (MI) and\u002For coronary heart disease with indication for a coronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 months prior to informed consent.\n15. ICD or right sided pacemaker placement within 2 months\n16. Clinically significant coagulation disorder, at discretion of investigator\n17. Patients with sepsis (local or generalized) or other acute infection(s) requiring systemic antibiotics in the two months prior enrollment\n18. Chronic kidney disease currently requiring dialysis\n19. Allergy to nickel and\u002For titanium and\u002For nickel\u002Ftitanium-based materials, if not medically manageable\n20. Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy\n21. Participating in another investigational clinical trial that could interfere with this study, at the discretion of the investigator\n22. Other clinically significant co-morbidities that make the patient unsuitable for study participation, at the discretion of the investigator\n\nNote: \\* LA pressure is substituted by PCW at the right heart catheterization measure while patient is awaken\n\n\\*\\*\"Corrected\" refers to a 4% reduction in the NT-proBNP cutoff for every increase of 1kg\u002Fm2 in body mass index (BMI) above a reference BMI of 20kg\u002Fm2)","ALL","18 Years",{"count":351,"type":352},150,"ESTIMATED","3 Years","OBSERVATIONAL","This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.",[357],"Heart Failure",[14,359,360,361,362,363,364,365,366,367,368,346],"Atrial Flow Regulator","Interatrial shunt device","Heart failure","HFrEF","HFpEF","Left-to-right shunt","Balloon atrial septostomy","MACNE","Device embolization","AFR","2026-06-05",{"date":371,"type":372},"2026-06-08","ACTUAL",{"date":374,"type":372},"2020-10-28",{"date":376,"type":352},"2031-06",{"name":5,"class":6},36]