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

May 3, 2011 updated by: CorAssist Cadiovascular Ltd.

ImCardia for DHF - Safety and Functionality

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • IMC 01
No Intervention: AVR control group
Aortic stenosis patients candidates for aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functionality - Successful Device implantation
Time Frame: Immediately post implantation day
The surgeon will score device implantation procedure post operation.
Immediately post implantation day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorAssist Cadiovascular Ltd.

Investigators

  • Study Director: Lea Lak, M.D., CorAssist Cardiovascular

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

May 3, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD 0201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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