The STIM-ADHF Study

Study Overview
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Brief Summary
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The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.

Detailed Description
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The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment.

Official Title
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Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Device: CPNS Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL LVEF ≤ 50% At least one sign/symptom of fluid overload At least one of the following: Inadequate diuretic response At least one sign or symptom of low perfusion Exclusion Criteria: Received an inotrope during current hospitalization Requires mechanical support Cardiogenic shock or impending cardiogenic shock Multi-organ failure Systolic blood pressure < 80mmHg or > 140mmHg Symptomatic hypotension eGFR < 25 mL/min/1.732 Severe hepatic disease

Ages Eligible for Study
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Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPNS Therapy<br>Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care. | Device: CPNS Therapy<br>* Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of related adverse events | The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, serious adverse events and deaths | Enrolment to 30 Days post hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurostimulation, Contractility, Right Pulmonary Artery