CompletedNCT02099448Updated Feb 9, 2016

Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP

An observational study in Heart Failure, sponsored by CorAlert Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by CorAlert Ltd. · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 41
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Heart Failure

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Heart Failure 5,697

In context

Heart Failure

5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 41 is below the median of 200 across 1,678 observational studies indexed under Heart Failure.

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Lead sponsor

This is the only study on the registry with CorAlert Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Subjects undergoing elective cardiac catheterization, during which LVED and aortic pressures are recorded

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 41 participants (actual)
Patient registry: No

Groups and cohorts

Elective Cardiac Catheterization

What researchers measure

Primary outcomes

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

Study locations

1 site

Kaplan Medical Center
Rehovot, Israel

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02099448
Lead sponsor: CorAlert Ltd.
Responsible party: Sponsor
First posted: Mar 28, 2014
Start date: Apr 2014
Primary completion: Mar 2015
Completion: Mar 2015
Last update: Feb 9, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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