Cardionomic STOP-ADHF Study

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

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.

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.

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