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Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study (CHOICE2)

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ClinicalTrials.gov Identifier: NCT01055210
Recruitment Status : Unknown
Verified January 2010 by University of Dundee.
Recruitment status was:  Not yet recruiting
First Posted : January 25, 2010
Last Update Posted : January 25, 2010
Sponsor:
Information provided by:
University of Dundee

Brief Summary:
An evaluation of the role of resting and exercise cardiac output measurement, by the inert gas rebreathing method, in optimisation of patients with cardiac resynchronisation pacemakers.

Condition or disease Intervention/treatment
Heart Failure Cardiac Resynchronisation Pacemakers Device: Optimisation of VV delay

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimisation of Cardiac Resynchronisation Therapy by Non-invasive Cardiac Output - The CHOICE2 Study
Study Start Date : February 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Intervention Details:
    Device: Optimisation of VV delay
    Programmed VV delay altered on device


Primary Outcome Measures :
  1. 6 minute hall walk test [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Echocardiographic measures of desynchrony [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardiac Resynchronization Device in situ for Heart Failure

Exclusion Criteria:

  • Unable to cope with mouthpiece
  • Estimated life expectancy < 6 months

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): NCT01055210


Locations
United Kingdom
University of Dundee Not yet recruiting
Dundee, United Kingdom
Contact: Anna Maria Choy    01382 632108    a.choy@dundee.ac.uk   
Principal Investigator: Anna Maria Choy         
Sponsors and Collaborators
University of Dundee
Investigators
Principal Investigator: Anna- Maria Choy University of Dundee

Responsible Party: Dr. Anna Maria Choy, University of Dundee
ClinicalTrials.gov Identifier: NCT01055210     History of Changes
Other Study ID Numbers: ELD002
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: January 25, 2010
Last Verified: January 2010

Keywords provided by University of Dundee:
Heart Failure
Pacemakers

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases