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
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
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
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
NCT ID
NCT01347125
First Posted
April 28, 2011
Last Updated
May 3, 2011
Sponsor
CorAssist Cadiovascular Ltd.
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
We'll reach out to this number within 24 hrs