Cardiac Failure Heart Failure
Conditions
Interventions
Sponsors
ENOPACE BIOMEDICAL LTD.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Subject at least 18 years of age but no more than 85 years old 2. Subject is a male or a postmenopausal female, or a female of childbearing age for whom pregnancy was excluded and who has accepted to use adequate contraception measures for the entire study duration 3. Subject is diagnosed as chronic heart failure NYHA class II-III 4. Subject is treated with diuretic(s) for heart failure *30 days prior to study entry 5. Subject has no other noncardiac disease that could account for his/her dyspnea 6. For a subject with left ventricular ejection fraction (LVEF) * 40% all of the following must be present: a) Left atrial enlargement > 25 cm2; b) LA volume index * 40ml/m2; c) Left ventricular hypertrophy as documented by echocardiogram with LVEDVI 300 pg/mL 7. For a subject with left ventricular ejection fraction (LVEF) 300 8. Subject should be receiving optimal medical treatment with no change in treatment in the previous 3 months (90 days) from enrolment with the exception of diuretic dosage; Optimal drug therapy as per current ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure . Subject has an average heart rate between 60 and 110 b/min recorded in a 24-h Holter measurement. 9. Subject is capable to walk a distance of 150-550 m in 6 minutes hall walk test. 10. Subject is willing to and capable of providing informed consent 11. Subject is capable of participating in all testing associated with this clinical investigation 12. Subject can comply with catheterization lab standard of care procedures
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Subject has been hospitalized for heart failure, diabetes or COPD within 30 days prior to enrolment 2. For a subject with left ventricular ejection fraction (LVEF) * 40%, the presence of chronic pulmonary disease requiring home oxygen therapy, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator 3. Subject with unstable angina, myocardial infarction, PTCA or coronary artery bypass graft within 180 days prior to enrolment 4. Subject with cerebral vascular accident or transient ischemic attack within 180 days prior to enrolment 5. Subject has resistant hypertension with systolic blood pressure * 180 mmHg within 30 days prior to enrolment 6. Subject has severe sclerosis or calcification of the thoracic aorta, as seen in CT scan 7. Subject has thoracic aorta abnormalities or disease e.g. aneurysm, dissection, extensive plaque, or implanted stent or stent graft, as seen in CT scan 8. Subject's anatomy is not compatible with the Harmony System, including that the aorta does not meet the appropriate anatomy (size and morphology) for implant placement based on Computed Tomography (CT) analysis. 9. Subject who has thoracic anatomy that does not enable adequate communication between implant and external unit as calculated by analyzing the CT scan, shall be excluded. 10. Subject diagnosed with severe aortic valve disease (severe aortic stenosis or aortic regurgitation) 11. Subject has severe mitral stenosis or grade 4 mitral regurgitation 12. Subject expected to undergo cardiac surgery during the study period 13. Subject whose heart failure is due to congenital heart disease 14. Subject diagnosed with Marfan Syndrome 15. Subject with moderate or severe chronic obstructive lung disease 16. Subject with renal insufficiency (eGFR 240msec, 2nd or 3rd degree AV block 20. Subject has history of brady-tachy arrhythmias 21. Subject with prior cardiac transplant or heart transplant candidate 22. Subject has infiltrative or restrictive cardiomyopathy 23. Subject had a vagotomy procedure in the past 24. Subject has a Body Mass Index (BMI) > 40 kg/m2 25. Subject with a life expectancy of less than 12 months, per physician judgment 26. Subject is a candidate within the 6 month follow up period for, or already has, a CRT and/or permanent pacemaker and is 100% pacemaker dependent 27. Subject who has an implantable cardioverter defibrillator that is affected by the Harmony System operation based on compatibility assessment during screening 28. Subject using any other medical electrical device 29. Subject involved in any concurrent clinical investigation 30. Subject has diseases or conditions which, in the judgment of the investigator, preclude participation in the clinical investigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of all system and/or procedure related adverse and serious adverse events up until 6 months post treatment activation.* | — |
Secondary
| Measure | Time frame |
|---|---|
| The assessment of change in the heart function after implant of the device . | — |
Countries
Netherlands
Outcome results
None listed