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

This study has been terminated.
(CorAssist believes that certain improvements are needed to the device)
Sponsor:
Information provided by:
CorAssist Cadiovascular Ltd.
ClinicalTrials.gov Identifier:
NCT01347125
First received: April 28, 2011
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Heart Failure With Normal Ejection Fraction
Device: ImCardia Device
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ImCardia for DHF - Safety and Functionality

Resource links provided by NLM:


Further study details as provided by CorAssist Cadiovascular Ltd.:

Primary Outcome Measures:
  • Safety: Adverse event reporting [ Time Frame: 36 month ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Immediately post implantation day ] [ Designated as safety issue: No ]
    The surgeon will score device implantation procedure post operation.


Enrollment: 19
Study Start Date: April 2008
Estimated Study Completion Date: May 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347125

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

No publications provided

Responsible Party: Dr. Lea Lak, CorAssist Cardiovascular Ltd.
ClinicalTrials.gov Identifier: NCT01347125     History of Changes
Other Study ID Numbers: CLD 0201
Study First Received: April 28, 2011
Last Updated: May 3, 2011
Health Authority: Latvia: State Agency of Medicines
Paraguay: Ministerio de Salud Pública y Bienestar Social
Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on August 26, 2014