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

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

Plain Language Summary

Simplified for easier understanding

This trial is testing a catheter-based procedure called pulmonary artery denervation — which disrupts overactive nerve signals in the lungs — in people with heart failure complicated by high blood pressure in the lungs (pulmonary hypertension), to see if it can improve heart and lung function. **You may be eligible if...** - You have heart failure with elevated pressure in your lung arteries (mean pulmonary artery pressure above 20 mmHg) - Your pulmonary vascular resistance is 3 or more units and your wedge pressure is above 15 mmHg - Your symptoms are NYHA Class II or III (moderate impairment) - Your kidney function is adequate (GFR at least 25 ml/min) **You may NOT be eligible if...** - You have severe valve disease (aortic or mitral) - Your life expectancy is less than 2 years - You cannot tolerate blood-thinning medications or right heart catheterization - You have had a recent heart attack or cardiac surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(3)

Hospital Universitari Germans Trias i Pujol

Badalona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

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NCT06495970


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