Acute Decompensated Heart Failure
Conditions
Keywords
Neurostimulation, Contractility, Right Pulmonary Artery
Brief summary
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
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.
Interventions
DEVICECPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
OTHERStandard of care
Available standard treatment
Sponsors
Cardionomic Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Measures | 6 months | The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths |
Countries
Belgium, Netherlands, Panama, United States
Outcome results
None listed