Cardionomic Cardiac Pulmonary Nerve Stimulation Pilot Study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Subjects must meet all the following inclusion criteria to be eligible to
participate in this study:
1. At least 18 years of age, or older if required by local law
2. Admitted to the hospital with a principal diagnosis of acute decompensated
heart failure.
3. BMI adjusted BNP >= 500 pg/mL or NT-pro-BNP >= 2000 pg/mL; 4% reduction in
BNP/NT-proBNP for every increase of 1 kg/m2 in BMI above a reference of 20kg/m2
(Refer to Appendix B: BNP/NT-proBNP corrected for BMI)
4. Left ventricular ejection fraction <= 45%; documented within previous 12
months
5. At least one sign or symptom of fluid overload
6. At least one of the following:
o Persistent inadequate diuretic response
o At least one sign or symptom of low perfusion

Exclusion Criteria

1. First IV treatment upon presentation in hospital to randomization is > 48
hours
2. Received an inotrope during current hospitalization or anticipated to
receive an inotrope in the 12 hours following enrollment
3. Requires mechanical support (e.g., mechanical circulatory support,
ultrafiltration) or anticipated to receive mechanical support in the 12 hours
following enrollment
4. Manually measured systolic blood pressure < 80 mmHg at screening
5. Manually measured systolic blood pressure > 130 mmHg at screening
6. Symptomatic hypotension
7. eGFR < 25 mL/min/1.73m2
8. Has an active infection
9. Has an active or passive implantable device that may interfere with CPNS
therapy per physician discretion
10. Has a cardiac resynchronization therapy (CRT) device or a pacemaker
11. Has an implantable cardioverter defibrillator (ICD) and is pacemaker
dependent or has had a sustained VT/VF episode in the previous 90 days (a
subject can be enrolled if he/she meets this criterion, the physician deems it
appropriate to suspend therapies during hospitalization and leads have been
implanted for at least six months prior to the study procedure) 12. Permanent
or persistent atrial fibrillation with uncontrolled ventricular response
(ventricular rate > 125 BPM) at time of enrollment
13. Unstable angina or documented myocardial infarction within last 30 days
14. Prior heart transplant
15. History of severe mitral or aortic stenosis or regurgitation
16. History of pulmonary embolism within the last 6 months
17. History of hyper-coagulation disorders
18. History of more than one CABG procedure
19. History of severe pulmonary hypertension (pulmonary arterial systolic
pressure >= 75 mmHg)
20. Diagnosis of primary pulmonary hypertension
21. Diagnosis of congenital heart disease
22. Participating in concurrent trial unless approved by Cardionomic study
manager
23. Pregnant or childbearing age and not on reliable form of birth control
24. Allergy to nickel, fentanyl, midazolam, propofol, heparin, eggs, egg
products, soybeans or soy products
25. Unwilling or unable to provide consent
26. Exclusion criteria by local law (e.g., age, prisoner, etc)