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

Heart Failure With Normal Ejection Fraction Clinical Trial

— ImCardia  

Official title:

ImCardia for DHF - Safety and Functionality

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01347125
• Other study ID #: CLD 0201
• Status: Terminated
• Phase: Phase 0
• First received: April 28, 2011
• Last updated: May 3, 2011
• Start date: April 2008
• Est. completion date: May 2012

Study information

• Verified date: May 2011
• Source: CorAssist Cadiovascular Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Latvia: State Agency of MedicinesParaguay: Ministerio de Salud Pública y Bienestar SocialRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Normal Ejection Fraction
• Heart Failure, Diastolic

Intervention

Device:
• ImCardia 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CorAssist Cadiovascular Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Functionality - Successful Device implantation	The surgeon will score device implantation procedure post operation.	Immediately post implantation day	No