Device Nerve Procedure for Lung Blood Pressure in Heart Failure Patients
Tests a device-based nerve procedure in heart failure patients with pulmonary hypertension.
Plain-language title generated from the registry record
Registry title: Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)
Key facts
- Where
- Badalona, Barcelona, and Valencia, SpainSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 85 years old?
Source: NCT06495970, who can take part
Where in Spain
- Hospital Universitari Germans Trias i PujolBadalona, SpainTaking people
- Hospital Universitari Vall d'HebronBarcelona, SpainTaking people
- Hospital Clinico Universitario de ValenciaValencia, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gradient Denervation Technologies
- Trial code
- NCT06495970
- Record updated
- 1 August 2025
- Original description
Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary HypertensionRead full original descriptionShow less
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
Inclusion: 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: Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel; Unable to tolerate right heart catheterization; 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; Life expectancy of < 2 years; Unwilling to provide informed consent or complete follow-up assessments; Severe aortic, mitral or pulmonary valve regurgitation; Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery).