Actively Recruiting
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Led by Gradient Denervation Technologies · Updated on 2025-08-01
20
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 OUS Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mean Pulmonary Artery Pressure (mPAP) greater than 20 mmHg at rest
- Pulmonary Vascular Resistance (PVR) of 3 Wood units or higher at rest
- Pulmonary Capillary Wedge Pressure greater than 15 mmHg at rest or greater than 18 mmHg with passive leg raise
- New York Heart Association (NYHA) Class II or III
- Glomerular Filtration Rate (GFR) of 25 ml/min or higher
You will not qualify if you...
- Unwillingness to provide informed consent or complete follow-up assessments
- Life expectancy less than 2 years
- Inability to take dual antiplatelet or anticoagulant therapy, or allergy to aspirin or clopidogrel
- Unable to tolerate right heart catheterization
- Severe aortic, mitral, or pulmonary valve regurgitation
- Presence of clot or thrombus in any planned target ablation zone of the pulmonary artery
- Systemic infection or localized infection/rash at the planned access site at the time of procedure
- Cardiac resynchronization therapy (CRT), implantable cardioverter defibrillator (ICD), pacemaker, or other interventional cardiac procedure (except right heart catheterization) within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Hospital Universitari Germans Trias i Pujol
Badalona, Spain, 08916
Actively Recruiting
2
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
3
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
Research Team
J
Julie Etheridge
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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