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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaplan Medical Center

Rehovot, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

CorAlert Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 28, 2014
Registry last updated: Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed