Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension Group 2 (PreVail-PH2 OUS Study)

Recruiting · NCT06495970 · Interventional (participants receive a specific treatment) · Lead sponsor: Gradient Denervation Technologies

Interventions studied

Gradient Denervation System

Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

Age range

22 Years to 85 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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

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

3 locations listed.