Tests a device for pulmonary artery denervation in heart failure with pulmonary hypertension
Tests a nerve-reducing device in adults with heart failure and high lung blood pressure.
Plain-language title generated from the registry record
Registry title: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Key facts
- Where
- Boston, Charleston, Chicago, Durham, Houston, Madison, and Milwaukee, United StatesSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 85 years old?
Source: NCT06052072, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Medical University of South CarolinaCharleston, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Duke UniversityDurham, United StatesNo longer taking part
- Baylor College of MedicineHouston, United StatesNo longer taking part
- Houston MethodistHouston, United StatesNo longer taking part
- University of WisconsinMadison, United StatesNo longer taking part
- Aurora HealthMilwaukee, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gradient Denervation Technologies
- Trial code
- NCT06052072
- Record updated
- 21 September 2026
- Original description
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 HypertensionRead full original descriptionShow less
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
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
Inclusion: 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 1 months prior treatment.
Exclusion: Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel; Unable to tolerate right heart catheterization; Ambulatory with a Life expectancy of < 1 years; 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 cirrhosis or congestive hepatopathy; Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery).