NL-OMON51129CompletedNot Applicable
Cardionomic Cardiac Pulmonary Nerve Stimulation Pilot Study - CPNS Pilot Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cardionomic Inc
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
- •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
- •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
- •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)
Investigators
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