Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Enrolling by invitation · Not applicable
Conditions studied: Group 2 Pulmonary Hypertension, Heart Failure
In brief
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
Key facts
- Study ID
- NCT06052072
- Run by
- Gradient Denervation Technologies
- People needed
- 50
- Starts
- 2024-02-20
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-05-19
Who can join
Age: 22 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 cirrhosis or congestive hepatopathy
- Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
Where it is running
- Northwestern University — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Duke University — Durham, North Carolina, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Baylor College of Medicine — Houston, Texas, United States
- Houston Methodist — Houston, Texas, United States
- University of Wisconsin — Madison, Wisconsin, United States
- Aurora Health — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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