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

Launched by GRADIENT DENERVATION TECHNOLOGIES · Sep 18, 2023

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ClinConnect Summary

The PreVail-PH2 Study is a clinical trial looking at a new treatment called pulmonary artery denervation for patients who have heart failure and a specific type of high blood pressure in the lungs, known as Group 2 Pulmonary Hypertension. The goal of this study is to see how this treatment affects the quality of life for these patients. The trial is currently recruiting participants aged 18 to 85 who have heart failure with a certain level of heart function and specific measurements of lung pressure.

To be eligible for this study, participants should have a heart failure diagnosis, a stable treatment plan for at least three months, and certain health measurements that meet the study's criteria. During the trial, participants will receive the pulmonary artery denervation treatment, which aims to help improve their symptoms and overall well-being. It's important to note that individuals with serious other medical conditions or certain heart issues may not qualify. This study represents an early step in understanding how this new approach can help improve the lives of those living with heart failure and pulmonary hypertension.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)