RecruitingNot ApplicableNCT06052072

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

Sponsor

Gradient Denervation Technologies

Enrollment

50 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Group 2 Pulmonary Hypertension

Summary

This early feasibility study is intended to 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 Criteria8

Heart Failure with EF ≥ 40% (by TTE within last 3 months)
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
Cardiac index (CI) ≥ 1.7 L/min/m2
NYHA Class II or III
Glomerular Filtration Rate (GFR) ≥ 25 ml/min
Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment

Exclusion Criteria7

Ambulatory with a Life expectancy of \< 1 years
Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel
Unable to tolerate right heart catheterization
Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device
Severe aortic, mitral or pulmonary valve regurgitation
Tricuspid regurgitation in conjunction with the presence of cirrhosis or congestive hepatopathy
Clot or Thrombus in any potential target ablation zone (right, left or main pulmonary artery)

Interventions

DEVICEGradient Denervation System

Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.