NCT01568619

Completed

Validation of Electrical Cardiometry Versus Fick Method in C...

Massachusetts General Hospital Source

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Other study identifiers

Sponsor study identifier

AESCULON

Study Type

observational

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

March 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2015

Actual (reported)

Study Completion

October 2015

Actual (reported)

Brief Summary

The investigators would like to find out if AESCULON®, a new device that non-invasively and continuously measures cardiac output using electrical cardiometry, works as well as one existing method--Fick method in patients undergoing cardiopulmonary exercise testing.

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): 30 participants
Study completion date: October 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.

Study Start
March 2012
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
March 29, 2012
Actual (reported)
First Posted
April 2, 2012
Actual (reported)
Primary Completion
October 2015
Actual (reported)
Study Completion
October 2015
Actual (reported)

Last Updated: January 18, 2017
Status Verified: January 2017
Last Update Submitted: January 15, 2017

Conditions

Heart Failure

Keywords

cardiopulmonary exercise testcardiac output

Outcome Measures

Primary Outcomes (1)

difference in CO measurements with two methods
the true difference between the two CO measurements is 10% of the mean CO
two weeks after finishing the exercise test

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Sampling MethodNon-Probability Sample

Study Population

Adult patients of 18 years or older who undergo cardiopulmonary exercise testing (CPET) with invasive hemodynamic monitoring for their routine care.

You may qualify if:

Age \>= 18 yd;

Sponsors & Collaborators

Massachusetts General Hospital
Otherlead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

Yandong Jiang, MD, PhD
Massachusetts General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 2, 2012

Study Start

March 2012

Date type not reported

This date has not been verified as actual or estimated.

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NCT01539629

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Level 3 cardiopulmonary exercise testing.

You may not qualify if:

Proven or suspected disease involving severe aortic regurgitation;
Implanted with a rate-responsive cardiac pacemaker;
Pneumothorax or pleural effusion;
Skin lesion(s) at the place where the electrode is supposed to be applied;
Allergic to adhesive of ECG electrodes.

Contact the study team to confirm eligibility.

Primary Completion

October 2015

Actual (reported)

Study Completion

October 2015

Actual (reported)

Last Updated

January 18, 2017

Record last verified: 2017-01

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: NCT01568619
Data provider: ClinicalTrials.gov
Source updated: 2017-01-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:28:08 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations