Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Trial Parameters
Brief Summary
This early feasibility study is intended to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Eligibility Criteria
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 * Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment Exclusion Criteria: * Ambulatory with a Life expectancy of \< 1 years * Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * Unable to tolerate right heart catheterization * Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device * Severe aortic, mitral or pulmonary valve regurgitation * Tricuspid regurgitation in conjunction with the presence of c