NCT06052072Enrolling by invitation
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 Study)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 18 Sept 2023
- Start date
- Feb 2024
- Primary completion date
- Jun 2027
- Lead sponsor
- Gradient Denervation Technologies
- NCT number
- NCT06052072
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Feb 2024 to the primary completion date, Jun 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
- Unable to tolerate right heart catheterization
Age
- Ambulatory with a Life expectancy of \< 1 years
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 22 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Houston Methodist Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Wisconsin Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Aurora Health Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.