Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.

Inclusion Criteria:

• 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
• NYHA Class II or III
• Glomerular Filtration Rate (GFR) ≥ 25 ml/min

Exclusion Criteria:

• Unwilling to provide informed consent or complete follow-up assessments
• Life expectancy of < 2 years
• Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
• Unable to tolerate right heart catheterization
• Severe aortic, mitral or pulmonary valve regurgitation
• Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
• Systemic infection or localized infection/rash at planned access site at time of procedure
• CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months