Acute Decompensated Heart Failure
Conditions
Keywords
Neurostimulation, Contractility, Right Pulmonary Artery
Brief summary
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
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.
Interventions
DEVICECPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Sponsors
Cardionomic Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of related adverse events | Enrolment to 30 Days post hospital discharge | 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 |
Countries
Hungary, Poland, Slovakia
Outcome results
None listed