Heart Failure With Normal Ejection FractionEarly Phase 1ImCardiaNCT01347125
ImCardia for DHF to Treat Diastolic Heart Failure (DHF) Patient a Pilot Study
A Early Phase 1 study testing ImCardia Device in people with Heart Failure With Normal Ejection Fraction, run by CorAssist Cadiovascular Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure With Normal Ejection Fraction
- What is being tested?
- ImCardia Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to May 2012
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
About this study
Official title: 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.
- Being tested
- ImCardia Device
- Keywords
- DHF (diastolic heart failure), HFNEF (heart failure with normal ejection fraction
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImCardia DeviceDevice
Also called IMC 01
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
| Study group | Role | What they receive |
|---|---|---|
| ImCardia | Experimental | Aortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device Receives: Device: ImCardia Device |
| AVR control group | No intervention | Aortic stenosis patients candidates for aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 month
Secondary outcomes (1)
Functionality - Successful Device implantation
The surgeon will score device implantation procedure post operation.
Measured: Immediately post implantation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startApr 2008
- Primary completionApr 2011
- Study completionMay 2012 (estimated)
Why it stopped: CorAssist believes that certain improvements are needed to the device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Normal Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorAssist Cadiovascular Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lea Lak, M.D., Study director, CorAssist Cardiovascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347125
- Sponsor's protocol ID
- CLD 0201
- Acronym
- ImCardia
- Status last verified
- May 2011
- First submitted
- 28 Apr 2011
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImCardia for DHF - Safety and Functionality
- ClinicalTrials.gov ID
- NCT01347125
- Acronym / sponsor ID
- ImCardia / CLD 0201
- Keywords
- DHF (diastolic heart failure), HFNEF (heart failure with normal ejection fraction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: CorAssist believes that certain improvements are needed to the device
- Enrolment
- 19 participants (actual)
- Lead sponsor
- CorAssist Cadiovascular Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2012 (estimated)
- First posted
- 4 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ImCardia | Experimental | Device: ImCardia DeviceAortic Stenosis patients candidates for Aortic Valve Replacement (AVR) implanted with the ImCardia device |
| AVR control group | No intervention | –Aortic stenosis patients candidates for aortic valve replacement |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImCardia DeviceAlso: IMC 01The 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 | Device | ImCardia |
Primary outcome
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
1 secondary outcome
Functionality - Successful Device implantation
Time frame: Immediately post implantation day
Results and safety
The study was stopped early (reason given: CorAssist believes that certain improvements are needed to the device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Lak, M.D. study director
CorAssist Cardiovascular
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ImCardia Device in people with Heart Failure With Normal Ejection Fraction, run by CorAssist Cadiovascular Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: CorAssist believes that certain improvements are needed to the device). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse event reporting (time frame: 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2011.