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

Early Phase 1

Terminated

• Conditions: Heart Failure With Normal Ejection Fraction
• Interventions: Device: ImCardia Device

• Registration Number: NCT01347125
• Lead Sponsor: CorAssist Cadiovascular Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2011-04
• Study First Submitted: 2011-04-28
• Status Verified: 2011-05
• Study First Submitted QC: 2011-05-03
• Last Update Submitted: 2011-05-03
• Study First Posted: 2011-05-04
• Last Update Posted: 2011-05-04
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ImCardia	ImCardia Device	Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Functionality - Successful Device implantation	Immediately post implantation day	The surgeon will score device implantation procedure post operation.