ImCardia for DHF to Treat Diastolic Heart Failure (DHF) Patient a Pilot Study

ImCardia for DHF - Safety and Functionality

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.

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