Atrial Flow Regulator in Heart Failure

Inclusion Criteria:

• Age ≥ 18 years

• Symptomatic heart failure (HF) in NYHA class III or IV ambulatory

• Optimal medical therapy of HF according to European Society of Cardiology (ESC)guidelines for last 6 months

• Hospitalization because of HF decompensation in last 12 months

• Absence of significant valvular disease requiring cardiac surgery

• Life expectancy ≥ 1 year

• Written informed consent obtained from the patient

• Left ventricle ejection fraction (LVEF) ≥ 15%

• Elevated left heart filling pressures:

1. Pulmonary artery wedge pressure (PAWP) at rest > 15 mmHg or

2. PAWP > 25 mmHg during hand grip test

Exclusion Criteria:

• Participation in another clinical trial in last 30 days

• Acute infection or sepsis

• Severe coagulation disorder

• Allergy to nickel or titanium

• Severe peripheral artery disease disabling 6 minutes walk test

• Allergy to antiplatelet drugs, oral anticoagulants or heparin

• Contraindication to trans-oesophageal echocardiography (TEE)

• Pregnancy

• Atrial septal defect (ASD) or presence of atrial septal occluder

• Severe patent foramen ovale (PFO) with significant left to right shunt in rest

• Intracardiac thrombus

• Acute coronary syndrome or Percutaneous Coronary Intervention (PCI) or Coronary ArteryBypass Grafting (CABG) in last 6 months

• Severe pulmonary hypertension:

1. Right atrial pressure ≥ PAWP (measured in right heart catheterization)

2. Right atrial pressure > 20 mmHg (measured in right heart catheterization)

• Planned heart transplantation

• Transient ischemic attack or stroke within last 6 months

• Cardiac resynchronisation therapy (CRT) within last 6 months