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 legraise

• 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 fora minimum of 3 months prior treatment

Exclusion Criteria:

• Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergyto aspirin or clopidogrel

• Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy thatwould prevent safe or proper use of the study device

• Systemic infection or localized infection/rash at planned access site at time ofprocedure

• Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident inthe 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