Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Gradient Denervation Technologies
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
Description
Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.
Eligibility
- Age range
- 22–85 years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- DeviceGradient Denervation System
Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.
Locations (8)
- Northwestern UniversityChicago, Illinois
- Massachusetts General HospitalBoston, Massachusetts
- Duke UniversityDurham, North Carolina
- Medical University of South CarolinaCharleston, South Carolina
- Baylor College of MedicineHouston, Texas
- Houston MethodistHouston, Texas