NCT02099448

Completed

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

CorAlert Ltd.Source

Other study identifiers

Sponsor study identifier

COR-01

Study Type

observational

Actual enrollment (reported)

41

Locations

1 country

Sites

1

Timeline

Study Start

April 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2015

Actual (reported)

Study Completion

March 2015

Actual (reported)

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 Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 41 participants
Study completion date: March 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 26, 2014
Actual (reported)
First Posted
March 28, 2014
Actual (reported)
Study Start
April 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)
Study Completion
March 2015
Actual (reported)

Last Updated: February 9, 2016
Status Verified: February 2016
Last Update Submitted: February 8, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

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
During elective cardiac catheterization

Study Arms (1)

Elective Cardiac Catheterization

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

Male subject between the ages of 18 - 80 years or postmenopausal female up to 80 years of age

Sponsors & Collaborators

CorAlert Ltd.
Industrylead

Study Sites (1)

Kaplan Medical Center

Rehovot, Israel

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Enrollment

41 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 28, 2014

Study Start

April 2014

Date type not reported

This date has not been verified as actual or estimated.

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

Willing and able to sign informed consent prior to study initiation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

March 2015

Actual (reported)

Study Completion

March 2015

Actual (reported)

Last Updated

February 9, 2016

Record last verified: 2016-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02099448
Data provider: ClinicalTrials.gov
Source updated: 2016-02-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:35 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Elective Cardiac Catheterization

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations