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

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)