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

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

Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life 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