Recruiting
Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
ClinicalTrials.gov IDNCT06495970
PhaseNA
Enrollment20
SponsorGradient Denervation Technologies
Age22 Years – 85 Years
SexALL
Conditions studied
Pulmonary Hypertension
About this study
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension
Interventions
- Device: Gradient Denervation System — The Gradient Denervation System delivers ultrasound ablation to planned locations in the pulmonary artery to down-regulate the sympathetic nervous drive. The system includes a sterile, single-use catheter that is designed to centrally position the transducer within the arterial target zone for consistency of ablation.
Primary outcomes
- Device related serious adverse events (30-days post-treatment)
Eligibility information
Inclusion Criteria:
* 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
* NYHA Class II or III
* Glomerular Filtration Rate (GFR) ≥ 25 ml/min
Exclusion Criteria:
* Unwilling to provide informed consent or complete follow-up assessments
* Life expectancy of \< 2 years
* Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
* Unable to tolerate right heart catheterization
* Severe aortic, mitral or pulmonary valve regurgitation
* Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)
* Systemic infection or localized infection/rash at planned access site at time of procedure
* CRT, ICD, Pacemaker or other Interventional cardiac procedure (except RHC) within the last 3 months
Study locations
- Hospital Universitari Germans Trias i Pujol, Badalona, 08916 Spain
- Hospital Universitari Vall d'Hebron, Barcelona, 08035 Spain
- Hospital Clínico Universitario de Valencia, Valencia, Spain
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-13.