Status:
RECRUITING
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Lead Sponsor:
Gradient Denervation Technologies
Conditions:
Group 2 Pulmonary Hypertension
Heart Failure
Eligibility:
All Genders
22-85 years
Phase:
NA
Brief 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
Detailed 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 ...
Eligibility Criteria
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 3 months prior treatment
Exclusion
- 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)
Key Trial Info
Start Date :
February 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06052072
Start Date
February 20 2024
End Date
July 1 2028
Last Update
December 17 2025
Active Locations (8)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Duke University
Durham, North Carolina, United States, 27708
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425