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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01347125
Recruitment Status : Terminated (CorAssist believes that certain improvements are needed to the device)
First Posted : May 4, 2011
Last Update Posted : May 4, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Heart Failure With Normal Ejection Fraction Device: ImCardia Device Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ImCardia for DHF - Safety and Functionality
Study Start Date : April 2008
Actual Primary Completion Date : April 2011
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: ImCardia
Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device
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
Other Name: IMC 01

No Intervention: AVR control group
Aortic stenosis patients candidates for aortic valve replacement

Primary Outcome Measures :
  1. Safety: Adverse event reporting [ Time Frame: 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 :
  1. Functionality - Successful Device implantation [ Time Frame: Immediately post implantation day ]
    The surgeon will score device implantation procedure post operation.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347125

Sponsors and Collaborators
CorAssist Cadiovascular Ltd.
Study Director: Lea Lak, M.D. CorAssist Cardiovascular

Responsible Party: Dr. Lea Lak, CorAssist Cardiovascular Ltd. Identifier: NCT01347125     History of Changes
Other Study ID Numbers: CLD 0201
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: May 4, 2011
Last Verified: May 2011

Keywords provided by CorAssist Cadiovascular Ltd.:
DHF (diastolic heart failure)
HFNEF (heart failure with normal ejection fraction

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases