Cardionomic STOP-ADHF Study

Study Overview
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Brief Summary
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STOP-ADHF Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.

Detailed Description
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The STOP-ADHF is a prospective, two-arm, multi-center study to evaluate the safety and performance of the CPNS System in patients with acute decompensated heart failure (ADHF). The CPNS System is a neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. The system consists of a temporary neuromodulation stimulator catheter and a stimulator. Approximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. Patients enrolled in the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients enrolled in the control arm in will receive standard treatment for their heart failure.

Official Title
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The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Device: CPNS Therapy
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to hospital with a principal diagnosis of ADHF BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL LVEF ≤ 50% At least one sign or symptom of fluid overload despite the administration of IV furosemide (or equivalent) (at least 40 mg or equivalent) Exclusion Criteria: Received a high dose inotrope or Levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment Requires mechanical support Cardiogenic shock or impending cardiogenic shock Systolic blood pressure < 80mmHg or > 140mmHg Symptomatic hypotension eGFR < 25 mL/min/1.732

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be enrolled in CPNS treatment arm or to the control arm. Treatment with CPNS system includes endovascular stimulation of the cardiac autonomic nerves in addition to standard of care. Subjects in the control arm will receive the available standard treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPNS Therapy<br>Treatment with CPNS system: 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>Other: Standard of care<br>* Available standard treatment<br>|
| Other: Standard of Care<br>Available standard treatment | Other: Standard of care<br>* Available standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Measures | The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths | 6 months | 

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