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OpenTrials
Completed

NCT Number: NCT01568619

Validation of Electrical Cardiometry Versus Fick Method in Cardiac Output Measurement

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Validation of Electrical Cardiometry Versus Fick Method to Measure Stroke Volume and Cardiac Output in Patients With or Suspected of Having Heart Failure

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2012
Registry last updated
Jan 18, 2017

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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