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

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

Plain Language Summary

Simplified for easier understanding

This study tests a procedure called pulmonary artery denervation — where nerve fibers around the pulmonary artery are disrupted using a special catheter — in heart failure patients who also have high blood pressure in their lung arteries (pulmonary hypertension). The goal is to reduce lung artery pressure and improve heart function. **You may be eligible if...** - You have heart failure with a preserved or mildly reduced pumping function - Your lung artery pressure is elevated and measured by a heart catheter procedure - You have been on stable, guideline-recommended heart failure treatment for at least 3 months - You are in NYHA functional class II or III (moderate symptoms) **You may NOT be eligible if...** - Your life expectancy is less than 1 year - You cannot take blood-thinning medications or have an allergy to aspirin or clopidogrel - You cannot tolerate a right heart catheter procedure - You have a pulmonary artery aneurysm or significant narrowing of the pulmonary artery 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

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


Locations(8)

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Duke University

Durham, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

University of Wisconsin

Madison, Wisconsin, United States

Aurora Health

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06052072


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