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Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

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ClinicalTrials.gov Identifier: NCT01568619
Recruitment Status : Completed
First Posted : April 2, 2012
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):
Yandong Jiang, Massachusetts General Hospital

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.

Condition or disease
Heart Failure

Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: Validation of Electrical Cardiometry Versus Fick Method to Measure Stroke Volume and Cardiac Output in Patients With or Suspected of Having Heart Failure
Study Start Date : March 2012
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. difference in CO measurements with two methods [ Time Frame: two weeks after finishing the exercise test ]
    the true difference between the two CO measurements is 10% of the mean CO

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Inclusion Criteria:

  • Age >= 18 yd;
  • Level 3 cardiopulmonary exercise testing.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568619

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Yandong Jiang, MD, PhD Massachusetts General Hospital

Responsible Party: Yandong Jiang, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01568619     History of Changes
Other Study ID Numbers: AESCULON
First Posted: April 2, 2012    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Yandong Jiang, Massachusetts General Hospital:
cardiopulmonary exercise test
cardiac output

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases