Heart Failure With Normal Ejection Fraction
Conditions
Keywords
DHF (diastolic heart failure), HFNEF (heart failure with normal ejection fraction
Brief summary
This study is designed to evaluate the ImCardia safety and to demonstrate system functionality in patients undergoing AV replacement with respect to 36 months follow up.
Interventions
DEVICEImCardia Device
The device operates by harnessing energy expended by the left ventricle (LV) during Systole and returning it to the heart during Diastole thereby making it available to augment diastolic performance
Sponsors
CorAssist Cadiovascular Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female able to understand and sign a informed consent 2. Be 50 years of age or older 3. NYHA class III, IV 4. EF \>55% 5. Candidates for aortic valve replacement due to aortic stenosis. 6. Agrees to attend all follow- up evaluations
Exclusion criteria
1. Free wall thickness less than11.5mm 2. Adhesions are expected from a previous surgery or medical condition (e.g. s/p chest radiation therapy etc.) 3. Presence of significant myocardial scars (e.g. postinfarction) at proposed site for implant of ImCardia™device Attachment screw. 4. Likely to be need CABG following the implantation of the ImCardia™ 5. Intra-cardiac thrombus/mass 6. Myocarditis 7. Acute/chronic pericarditis 8. Not a candidate for sternotomy 9. Active infection 10. Stroke, surgery or ICD within 3 months 11. Acute coronary syndrome during the past 6 months 12. Left ventricular regional wall motion abnormalities 13. Significant valvular disease other that aortic stenosis 14. Significant pulmonary disease 15. A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator 16. Participating in another trial (other than non-therapeutic or interventional observation) within the last 60 days. 17. History of noncompliance to medical therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Adverse event reporting | 36 month | Adverse event reporting will continue up to 36 month follow up. Any complication attributed to the device will be recorded. Any Major Adverse Cardiac Event (MACE) will be evaluated in a safety committee composed from company representative and a cardiosurgeon which is not part of the company |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functionality - Successful Device implantation | Immediately post implantation day | The surgeon will score device implantation procedure post operation. |
Outcome results
None listed