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

Study Overview
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Brief Summary
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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.

Official Title
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ImCardia for DHF - Safety and Functionality

Conditions
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Heart Failure With Normal Ejection Fraction

Intervention / Treatment
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* Device: ImCardia Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female able to understand and sign a informed consent Be 50 years of age or older NYHA class III, IV EF >55% Candidates for aortic valve replacement due to aortic stenosis. Agrees to attend all follow- up evaluations Exclusion Criteria: Free wall thickness less than11.5mm Adhesions are expected from a previous surgery or medical condition (e.g. s/p chest radiation therapy etc.) Presence of significant myocardial scars (e.g. postinfarction) at proposed site for implant of ImCardia™device Attachment screw. Likely to be need CABG following the implantation of the ImCardia™ Intra-cardiac thrombus/mass Myocarditis Acute/chronic pericarditis Not a candidate for sternotomy Active infection Stroke, surgery or ICD within 3 months Acute coronary syndrome during the past 6 months Left ventricular regional wall motion abnormalities Significant valvular disease other that aortic stenosis Significant pulmonary disease 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 Participating in another trial (other than non-therapeutic or interventional observation) within the last 60 days. History of noncompliance to medical therapy

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ImCardia<br>Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device | Device: ImCardia Device<br>* 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<br>* Other names: IMC 01;|
| No Intervention: AVR control group<br>Aortic stenosis patients candidates for aortic valve replacement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Adverse event reporting | 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 | 36 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality - Successful Device implantation | The surgeon will score device implantation procedure post operation. | Immediately post implantation day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHF (diastolic heart failure), HFNEF (heart failure with normal ejection fraction