CPNS Pilot Study: Evaluation of Safety and Performance of the Cardiac Pulmonary Nerve Stimulation (CPNS) System in Patients With ADHF

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Cardionomic Inc.
Updated on 10 May 2022


The CPNS Pilot 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 CPNS Pilot Study is a prospective, multi-center and multinational study to evaluate the safety and performance of the CPNS System in patients hospitalized 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-discharges from the hospital. Patients assigned to the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients randomized to the control arm in Phase 2 will receive standard treatment for their heart failure.

Condition Acute Decompensated Heart Failure
Treatment Standard of Care, CPNS Therapy
Clinical Study IdentifierNCT04814134
SponsorCardionomic Inc.
Last Modified on10 May 2022


Yes No Not Sure

Inclusion Criteria

Admitted to hospital with a principal diagnosis of ADHF
BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
LVEF ≤ 45%
At least one sign/symptom of fluid overload
At least one of the following
inadequate diuretic response
least one sign or symptom of low perfusion

Exclusion Criteria

First IV treatment upon presentation in hospital to randomization > 48 hours
Received an inotrope or anticipated to receive an inotrope in the 12 hours following enrollment
Requires mechanical support or anticipated to receive mechanical support in the 12 hours following enrollment
Systolic blood pressure < 80mmHg or > 130mmHg
Symptomatic hypotension
eGFR < 25 mL/min/1.732
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