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

Prior treatment

• 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

Other illness

• 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)

Lab values

• Allergy to anti-platelet, anti-coagulant or anti-thrombotic therapy

Other

• 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

• 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