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

Study Overview
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Brief Summary
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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

Detailed Description
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Gradient has developed a novel system for pulmonary artery denervation (PADN) to treat patients with heart failure who also developed pulmonary hypertension (PH). Pulmonary hypertension is frequently associated with left heart failure and is a strong independent predictor of clinical worsening and higher mortality. No therapeutic options are available to treat PH in this selected group of patients with heart failure. The objective is to improve exercise capacity and quality of life by targeting PH in these patients.

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

Conditions
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Group 2 Pulmonary Hypertension, Heart Failure

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) ≥ 1.2 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: Life expectancy of < 2 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)

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: Prospective, single arm, multi-center, early feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PADN with Gradient Denervation System<br>Procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation. | Device: Gradient Denervation System<br>* Pulmonary artery denervation (PADN) procedure using the Gradient Denervation System to ablate nerves within the pulmonary artery using ultrasonic ablation.<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 | Number and frequency of serious adverse events deemed to be related to the investigational device and/or procedure. | Through 30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PVR | Mean change from baseline in PVR | Measured at 1- and 6- months post-procedure |