A Prospective, Multicenter, Open Label, Single Arm, Study to Assess the Safety & Performance of the Harmony Aortic Stimulation System (HASS) for the Treatment of Heart Failure
- Conditions
- Cardiac FailureHeart Failure10019280
- Registration Number
- NL-OMON46909
- Lead Sponsor
- ENOPACE BIOMEDICAL LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
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 < 97 mL/m2;
d) NT-proBNP > 300 pg/mL
7. For a subject with left ventricular ejection fraction (LVEF) < 40%, subject has an elevated NT-proBNP >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
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<35)
17. Subject is allergic to iodine or contrast media
18. Subject is unable to take anticoagulants or antiplatelet agents
19. Subject has a 1st degree AV block with PR interval > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The occurrence of all system and/or procedure related adverse and serious<br /><br>adverse events up until 6 months post treatment activation.*</p><br>
- Secondary Outcome Measures
Name Time Method <p>The assessment of change in the heart function after implant of the device .</p><br>