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

February 8, 2016 updated by: CorAlert Ltd.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Rehovot, Israel
        • Kaplan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age
  2. Patient undergoing elective cardiac catheterization during which LVED and aortic pressures are recorded
  3. Willing and able to sign informed consent prior to study initiation

Exclusion Criteria:

  1. Subject has a baseline heart rate of < 60 or >100 beats/min
  2. Subject has moderate to severe valvular disease
  3. Subject suffers from atrial fibrillation or other tachyarrhythmias
  4. Subject suffers from hemodynamic instability
  5. Subject is candidate for primary PCI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Elective Cardiac Catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
During elective cardiac catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorAlert Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

March 26, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

February 9, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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