Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of Left Ventricular End Diastolic Pressure (LVEDP)

CorAlert Ltd.1 site in 1 country41 target enrollmentApril 2014

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: CorAlert Ltd.
Enrollment: 41
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

March 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

CorAlert Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

•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

Outcomes

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