Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension

Study Overview
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Brief Summary
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Prospective, single-arm, multicenter First in Human study to characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Pulmonary Hypertension

Official Title
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Pulmonary Artery DenerVation Clinical Study Using the Gradient Denervation System in Heart Failure Patients With Pulmonary Hypertension

Conditions
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Heart Failure Patients With Pulmonary Hypertension

Intervention / Treatment
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* Device: Gradient Denervation System


Participation Criteria
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Eligibility Criteria
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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 N-terminal pro-B-type natriuretic peptide (NT-proBNP) ≥ 400pg/mL Stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment Exclusion Criteria: Inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel Pulmonary artery aneurysm, moderate or greater PA stenosis or other PA anatomy that would prevent safe or proper use of the study device Systemic infection or localized infection/rash at planned access site at time of procedure Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months CRT or other Interventional cardiac procedure (except RHC) within last 3 months Any planned cardiac procedure or inpatient procedure within the next 30 days

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, single arm, multi-center study designed to evaluate the safety, and feasibility of the Gradient Denervation System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PADN with Gradient Denervation System<br> | Device: Gradient Denervation System<br>* Pulmonary artery denervation (PADN) procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device and procedure related serious adverse events |  | 30 days post-ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in Pulmonary Vascular Resistance (woods units) |  | 30 and 120 days post-ablation | 
| Mean change from baseline in 6MWT distance (m) |  | 30 and 120 days post-ablation |