RecruitingNot ApplicableNCT06495970

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

Sponsor

Gradient Denervation Technologies

Enrollment

20 participants

Start Date

Jun 26, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension

Summary

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

Eligibility

Min Age: 22 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria8

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

Interventions

DEVICEGradient 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.