Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension

Inclusion criteria

• Heart Failure with EF ≥ 40% (by TTE within last 3 months)
• Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest
• Pulmonary Vascular Resistance (PVR) ≥ 3WU at rest
• Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise
• Cardiac index (CI) ≥ 1.7 L/min/m2
• NYHA Class II or III
• Glomerular Filtration Rate (GFR) ≥ 25 ml/min
• N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL
• Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment

Exclusion criteria

• Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
• Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
• Systemic infection or localized infection/rash at planned access site at time of procedure
• Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months
• CRT or other Interventional cardiac procedure (except RHC) within last 3 months
• Any planned cardiac procedure or inpatient procedure within the next 30 days