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