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

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 ormore 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 atrialfibrillation (AF)

6. Stable guideline directed treatment according to latest applicable ESC guidelinesfor 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 heartfailure, or listed for heart transplantation at time of baseline visit

2. Evidence of right heart failure defined (by ECHO) as:

3. Severe Right Ventricular Dysfunction (TAPSE < 14 mm)

4. Severe Right Ventricular Dilatation (RV volume ≥ LV volume)

5. Severe pulmonary hypertension (PASP > 60 mm Hg)

6. Echocardiographic evidence of intra-cardia mass, thrombus or vegetation

7. Uncontrolled hypertension, Systolic Blood Pressure of >160 mmHg or Diastolic BloodPressure ≥ 100mmHg, despite medical therapy at the time of screening visit.

8. Uncontrolled atrial fibrillation with resting heart rate >110bpm, despite medicaltherapy

9. Documented history of specific cardiomyopathy (obstructive hypertrophic,restrictive, infiltrative) or pericardial disease

10. Congenital heart defect that interferes with placement of the device, at thediscretion of the Investigator.

11. Previous interventional or surgical atrial septal defect (ASD) or patent foramenovale (PFO) closure interfering with the placement of the device

12. Current atrial septal defect, or anatomical anomaly (including > 10 mm atrial septalthickness or atrial septal aneurysm) on ECHO that precludes implantation of thedevice across the fossa ovalis (FO) of the interatrial septum

13. Clinically significant valvular heart disease:

14. regurgitation grade ≥3+ or

15. severe stenosis of mitral or tricuspid valves, or

16. significant stenosis of aortic valves

17. Prior diagnosis of primary pulmonary hypertension

18. Severe Chronic Obstructive Pulmonary Disease (COPD) requiring oral steroid therapyor oxygen administration

19. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), orpulmonary emboli within 6 months, or any prior stroke with persistent neurologicdeficit, or any prior intracranial bleed, or known intracerebral aneurysm, AVmalformation or other intracranial pathology increasing the risk of bleeding

20. Myocardial Infarction (MI) and/or coronary heart disease with indication for acoronary intervention or Coronary Artery Bypass Grafting (CABG) or within 2 monthsprior to informed consent.

21. ICD or right sided pacemaker placement within 2 months

22. Clinically significant coagulation disorder, at discretion of investigator

23. Patients with sepsis (local or generalized) or other acute infection(s) requiringsystemic antibiotics in the two months prior enrollment

24. Chronic kidney disease currently requiring dialysis

25. Allergy to nickel and/or titanium and/or nickel/titanium-based materials, if notmedically manageable

26. Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy

27. Participating in another investigational clinical trial that could interfere withthis study, at the discretion of the investigator

28. Other clinically significant co-morbidities that make the patient unsuitable forstudy 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)