Heart FailureNCT02099448
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP
An observational study of Heart Failure, run by CorAlert Ltd. at 1 site in Israel.
Trial summary
The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Mar 2015
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing elective cardiac catheterization, during which LVED and aortic pressures are recorded
Who may be able to join
- Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age
- Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded
- Willing and able to sign informed consent prior to study initiation
Who cannot join
- Subject has a baseline heart rate of < 60 or >100 beats/min
- Subject has moderate to severe valvular disease
- Subject suffers from atrial fibrillation or other tachyarrhythmias
- Subject suffers from hemodynamic instability
- Subject is candidate for primary PCI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of Left Ventricular End Diastolic Pressure (LVEDP)
The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elective Cardiac Catheterization | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization
Measured: During elective cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorAlert Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099448
- Sponsor's protocol ID
- COR-01
- Status last verified
- Feb 2016
- First submitted
- 26 Mar 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of Left Ventricular End Diastolic Pressure (LVEDP)
- ClinicalTrials.gov ID
- NCT02099448
- Acronym / sponsor ID
- COR-01
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CorAlert Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 28 Mar 2014 (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.
The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP using the investigational device C.A 2.0.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective Cardiac Catheterization | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing elective cardiac catheterization, during which LVED and aortic pressures are recorded
Key inclusion criteria (3 listed)
- Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age
- Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded
- Willing and able to sign informed consent prior to study initiation
Key exclusion criteria (5 listed)
- Subject has a baseline heart rate of < 60 or >100 beats/min
- Subject has moderate to severe valvular disease
- Subject suffers from atrial fibrillation or other tachyarrhythmias
- Subject suffers from hemodynamic instability
- Subject is candidate for primary PCI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization
Time frame: During elective cardiac catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by CorAlert Ltd. at 1 site in Israel.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Establish the accuracy of the non-invasive device, C.A 2.0, to estimate LVEDP comparing it to the invasive hemodynamic measurement via left heart catheterization (time frame: During elective cardiac catheterization). 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 9 Feb 2016.