Actively Recruiting
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Led by Gradient Denervation Technologies · Updated on 2025-12-17
50
Participants Needed
8
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Heart Failure with EF 64 40% (by TTE within last 3 months)
- Mean Pulmonary Artery Pressure (mPAP) >20 mmHg at rest
- Pulmonary Vascular Resistance (PVR) 64 3WU at rest
- Pulmonary Capillary Wedge Pressure > 15 mmHg (at rest) or > 18 with passive leg raise
- Cardiac index (CI) 64 1.7 L/min/m2
- NYHA Class II or III
- Glomerular Filtration Rate (GFR) 64 25 ml/min
- Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment
You will not qualify if you...
- 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)
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Duke University
Durham, North Carolina, United States, 27708
Actively Recruiting
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
5
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
6
Houston Methodist
Houston, Texas, United States, 77030
Actively Recruiting
7
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
8
Aurora Health
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
Research Team
J
Jason McCarthy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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