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

Primary Purpose

Heart Failure With Normal Ejection Fraction

Status
Terminated
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
ImCardia Device
Sponsored by
CorAssist Cadiovascular Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Normal Ejection Fraction focused on measuring DHF (diastolic heart failure), HFNEF (heart failure with normal ejection fraction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    ImCardia

    AVR control group

    Arm Description

    Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device

    Aortic stenosis patients candidates for aortic valve replacement

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Functionality - Successful Device implantation
    The surgeon will score device implantation procedure post operation.

    Full Information

    First Posted
    April 28, 2011
    Last Updated
    May 3, 2011
    Sponsor
    CorAssist Cadiovascular Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01347125
    Brief Title
    ImCardia for DHF to Treat Diastolic Heart Failure (DHF) Patient a Pilot Study
    Acronym
    ImCardia
    Official Title
    ImCardia for DHF - Safety and Functionality
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    CorAssist believes that certain improvements are needed to the device
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    May 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    CorAssist Cadiovascular Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure With Normal Ejection Fraction
    Keywords
    DHF (diastolic heart failure), HFNEF (heart failure with normal ejection fraction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ImCardia
    Arm Type
    Experimental
    Arm Description
    Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device
    Arm Title
    AVR control group
    Arm Type
    No Intervention
    Arm Description
    Aortic stenosis patients candidates for aortic valve replacement
    Intervention Type
    Device
    Intervention Name(s)
    ImCardia Device
    Other Intervention Name(s)
    IMC 01
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Safety: Adverse event reporting
    Description
    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
    Time Frame
    36 month
    Secondary Outcome Measure Information:
    Title
    Functionality - Successful Device implantation
    Description
    The surgeon will score device implantation procedure post operation.
    Time Frame
    Immediately post implantation day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lea Lak, M.D.
    Organizational Affiliation
    CorAssist Cardiovascular
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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